Trial Outcomes & Findings for Ph1 Study of SL-172154 Administered Intratumorally in Subjects With Squamous Cell Carcinoma of the Head and Neck or Skin (NCT NCT04502888)

NCT ID: NCT04502888

Last Updated: 2025-02-24

Results Overview

Number of participants with treatment-emergent adverse events

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 5 participants
• Primary outcome timeframe: From Day 1 to 90 days after last injection of SL-172154, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
• Results posted on: 2025-02-24

Participant Flow

Participant milestones

Measure	SL-172154 (0.003 mg) 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) 0.01 mg of SL-172154 via intratumoral injection
Overall Study STARTED	3	2
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ph1 Study of SL-172154 Administered Intratumorally in Subjects With Squamous Cell Carcinoma of the Head and Neck or Skin

Baseline characteristics by cohort

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	70.0 years n=5 Participants	63.5 years n=7 Participants	70.0 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Cancer type cutaneous squamous cell carcinoma	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Cancer type squamous cell carcinoma of the head and neck	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 to 90 days after last injection of SL-172154, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.

Number of participants with treatment-emergent adverse events

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Incidence of All Treatment Emergent Adverse Events	3 Participants	2 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 29.

Population: DLT evaluable population

Number of participants with dose limiting toxicities (DLTs)

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Maximum Tolerated Dose (MTD) of SL-172154 When Administered Intratumorally	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 18-24 months

Based on review of all data, including safety, tolerability, PK, anti-tumor activity and PD effects

Outcome measures

Measure	SL-172154 (0.003 mg) n=5 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) 0.01 mg of SL-172154 via intratumoral injection
Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered by Intratumoral Injection (ITI)	NA mg Study was terminated early, prior to determination of the RP2D	—

SECONDARY outcome

Timeframe: Approximately 18-24 months

Population: Response Evaluable Population

Number of participants with an objective response per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Objective response includes complete response (disappearance of all target lesions) and partial response (>/= 30% decrease in the sum of the longest diameter of target lesions).

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Objective Response Rate of SL-172154 When Administered by Intratumoral Injection (ITI)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 18-24 months

Population: Due to the small number of subjects and limited systemic exposure SL-172154 by ITI, samples were not analyzed for the presence of anti-drug antibodies to SL-172154.

Proportion of participants with positive anti-drug antibody titer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 18-24 months

The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Maximum Observed Concentration (Cmax) of SL-172154 When Administered by Intratumoral Injection (ITI)	NA ng/mL Geometric Coefficient of Variation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.	NA ng/mL Geometric Coefficient of Variation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.

SECONDARY outcome

Timeframe: Approximately 18-24 months

The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Time at Which the Maximum Concentration is Observed (Tmax) of SL-172154 When Administered by Intratumoral Injection (ITI)	NA hours The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.	NA hours The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.

SECONDARY outcome

Timeframe: Approximately 18-24 months

The Cmin is the minimum observed serum concentration of SL-172154 following single and multiple doses

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Minimum Observed Concentration (Cmin) of SL-172154 When Administered by Intratumoral Injection (ITI)	NA ng/mL Geometric Coefficient of Variation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.	NA ng/mL Geometric Coefficient of Variation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.

SECONDARY outcome

Timeframe: Approximately 18-24 months

The AUC is the area under the serum concentration time curve following single and multiple doses of SL-172154

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Area Under the Serum Concentration Time Curve (AUC) of SL-172154 When Administered by Intratumoral Injection (ITI)	NA hours*ng/mL Geometric Coefficient of Variation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.	NA hours*ng/mL Geometric Coefficient of Variation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.

SECONDARY outcome

Timeframe: Approximately 18-24 months

Terminal elimination half-life (t1/2) of SL-172154

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Terminal Elimination Half-life (t1/2) of SL-172154 When Administered by Intratumoral Injection (ITI)	NA hours Standard Deviation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.	NA hours Standard Deviation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.

SECONDARY outcome

Timeframe: Approximately 18-24 months

Clearance of Sl-172154

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Clearance (CL) of SL-172154 When Administered by Intratumoral Injection (ITI)	NA liters per hours Standard Deviation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.	NA liters per hours Standard Deviation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.

SECONDARY outcome

Timeframe: Approximately 18-24 months

Volume of distribtion of SL-172154

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
Volume of Distribution of SL-172154 When Administered by Intratumoral Injection (ITI)	NA liters Standard Deviation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.	NA liters Standard Deviation NA The serum concentration of SL-172154 was below the limit of quantitation in all samples collected during the study.

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 18-24 months

Population: Due to the small number of subjects and Sponsor decision to pursue development of SL-172154 by IV administration, a complete set of PD samples was not analyzed or reported.

Circulating immune cells such as: T cells, B cells, natural killer (NK) cells, and myeloid cells and circulating chemokine and cytokine levels

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 18-24 months

Population: Due to the small number of subjects and Sponsor decision to pursue development of SL-172154 by IV administration, a complete set of PD samples was not analyzed or reported.

Presence of SL-172154 in tumor tissue, changes in T cells subsets, B cells and macrophages and assessment of SL-172154 in the tumor tissue, CD47 and CD40 expression and Programmed cell death ligand 1 (PD-L1) expression

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 18-24 months

PFS: time from first dose to progression by RECIST v1.1 or death, whichever comes first

Outcome measures

Measure	SL-172154 (0.003 mg) n=3 Participants 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 Participants 0.01 mg of SL-172154 via intratumoral injection
To Estimate Progression-free Survival (PFS)	NA weeks Standard Deviation NA Due to the small number of subjects, PFS data was not informative.	NA weeks Standard Deviation NA Due to the small number of subjects, PFS data was not informative.

Adverse Events

SL-172154 (0.003 mg)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

SL-172154 (0.01 mg)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	SL-172154 (0.003 mg) n=3 participants at risk 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 participants at risk 0.01 mg of SL-172154 via intratumoral injection
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.

Other adverse events

Measure	SL-172154 (0.003 mg) n=3 participants at risk 0.003 mg of SL-172154 via intratumoral injection	SL-172154 (0.01 mg) n=2 participants at risk 0.01 mg of SL-172154 via intratumoral injection
General disorders Injection site pain	66.7% 2/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
General disorders Chills	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
General disorders Face oedema	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
General disorders Fatigue	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
General disorders Injection site haemorrhage	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
General disorders Oedema peripheral	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Infections and infestations COVID-19	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Infections and infestations Lymph gland infection	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Infections and infestations Rash pustular	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Infections and infestations Wound infection staphylococcal	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Musculoskeletal and connective tissue disorders Flank pain	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Musculoskeletal and connective tissue disorders Trismus	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	100.0% 2/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Gastrointestinal disorders Constipation	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Gastrointestinal disorders Nausea	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Gastrointestinal disorders Odynophagia	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Injury, poisoning and procedural complications Arthropod bite	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Injury, poisoning and procedural complications Post procedural haemorrhage	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Metabolism and nutrition disorders Hyperkalaemia	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Nervous system disorders Dizziness	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Nervous system disorders Headache	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Nervous system disorders Paraesthesia	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Psychiatric disorders Confusional state	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Psychiatric disorders Irritability	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Investigations Blood creatinine increased	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Renal and urinary disorders Pollakiuria	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	0.00% 0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.	50.0% 1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.

Additional Information

VP, Clinical Operations

Shattuck Labs

Phone: 919-864-2700

Email: clinicaltrials@shattucklabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee Site agrees not to publish any Study Results or data before the publication of results from the Overall Study. After Sponsor haspublished the results of the Overall Study, Site may publish or present results generated at Site. If Sponsor has not publishedresults of the Overall Study within 18 months of data base lock, Site may publish the results of the Study that were generated atSite. Site agrees to first submit to Sponsor the proposed publication at least 30 days prior to the submission.
• Publication restrictions are in place

Restriction type: OTHER