Trial Outcomes & Findings for SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma (NCT NCT04205630)

NCT ID: NCT04205630

Last Updated: 2024-05-30

Results Overview

ORR is defined as the proportion of patients with an assessed best overall response of complete response or partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2024-05-30

Participant Flow

A total of 80 participants were screened, out of which 64 patients were enrolled in the study.

Participant milestones

Measure	SYD985 SYD985, Intravenous, 1.2 mg/kg once every 3 weeks (Q3W)
Overall Study STARTED	64
Overall Study Full Analysis Set (All Patients Who Received at Least 1 Dose of Study Treatment)	64
Overall Study Efficacy Analysis Set (All Patients Who Had at Least One Post-baseline Tumour Evaluation Assessment)	61
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	64

Reasons for withdrawal

Measure	SYD985 SYD985, Intravenous, 1.2 mg/kg once every 3 weeks (Q3W)
Overall Study Disease progression per RECIST 1.1	37
Overall Study Disease clinical progression	7
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	17
Overall Study Other	1

Baseline Characteristics

SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma

Baseline characteristics by cohort

Measure	SYD985 n=64 Participants SYD985, Intravenous, every 3 weeks (Q3W) SYD985: Powder for concentrate for solution for infusion
Age, Continuous	66.3 years STANDARD_DEVIATION 7.31 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment South Korea	7 participants n=5 Participants
Region of Enrollment Singapore	5 participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Region of Enrollment Ukraine	19 participants n=5 Participants
Region of Enrollment Poland	4 participants n=5 Participants
Region of Enrollment Serbia	6 participants n=5 Participants
Region of Enrollment Russia	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Efficacy analysis set (EAS) was used for the efficacy analyses. The EAS consists of a subset of the full analysis set (FAS) patients who had a baseline and at least one post-baseline tumour evaluation assessment.

ORR is defined as the proportion of patients with an assessed best overall response of complete response or partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

Outcome measures

Measure	SYD985 n=61 Participants SYD985, Intravenous, every 3 weeks (Q3W)
Objective Response Rate (ORR)	20 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Progression-free survival is measured for the Full Analysis Set (FAS).

PFS is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier.

Outcome measures

Measure	SYD985 n=64 Participants SYD985, Intravenous, every 3 weeks (Q3W)
Progression-Free Survival (PFS)	5.6 months Interval 4.0 to 7.6

SECONDARY outcome

Timeframe: 2 years

OS is defined as the time from date of randomization to death due to any cause.

Outcome measures

Measure	SYD985 n=64 Participants SYD985, Intravenous, every 3 weeks (Q3W)
Overall Survival (OS)	16.3 months Interval 11.6 to 20.5

SECONDARY outcome

Timeframe: 2 years

AEs will be graded by the investigator as assessed by CTCAE v5.0.

Outcome measures

Measure	SYD985 n=64 Participants SYD985, Intravenous, every 3 weeks (Q3W)
Number of Participants With Treatment-Emergent Adverse Events (AEs)	51 Participants

Adverse Events

SYD985

Serious events: 12 serious events

Other events: 51 other events

Deaths: 36 deaths

Serious adverse events

Measure	SYD985 n=64 participants at risk SYD985, Intravenous, every 3 weeks (Q3W)
Gastrointestinal disorders Abdominal hernia	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Gastrointestinal disorders Nausea	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Gastrointestinal disorders Oesophageal haemorrhage	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Infections and infestations COVID-19 pneumonia	4.7% 3/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Blood and lymphatic system disorders Anaemia	3.1% 2/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Cardiac disorders Cardiac failure	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Cardiac disorders Cardiac failure acute	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
General disorders General physical health deterioration	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
General disorders Sudden death	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Musculoskeletal and connective tissue disorders Flank pain	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour	1.6% 1/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.

Other adverse events

Measure	SYD985 n=64 participants at risk SYD985, Intravenous, every 3 weeks (Q3W)
Eye disorders Keratitis	31.2% 20/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Eye disorders Dry eye	28.1% 18/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Eye disorders Conjunctivitis	21.9% 14/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Eye disorders Periorbital oedema	10.9% 7/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Eye disorders Lacrimation increased	7.8% 5/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Eye disorders Vision blurred	7.8% 5/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	17.2% 11/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Skin and subcutaneous tissue disorders Alopecia	10.9% 7/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
General disorders Fatigue	14.1% 9/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
General disorders Pyrexia	9.4% 6/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Blood and lymphatic system disorders Anaemia	12.5% 8/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Blood and lymphatic system disorders Leukopenia	10.9% 7/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Blood and lymphatic system disorders Neutropenia	10.9% 7/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Blood and lymphatic system disorders Thrombocytopenia	6.2% 4/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Gastrointestinal disorders Nausea	7.8% 5/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Gastrointestinal disorders Constipation	6.2% 4/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Gastrointestinal disorders Diarrhoea	6.2% 4/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Gastrointestinal disorders Dry mouth	6.2% 4/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Gastrointestinal disorders Stomatitis	6.2% 4/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Nervous system disorders Dysgeusia	7.8% 5/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Nervous system disorders Peripheral sensory neuropathy	6.2% 4/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Metabolism and nutrition disorders Decreased appetite	10.9% 7/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Injury, poisoning and procedural complications Infusion related reaction	12.5% 8/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.
Investigations Weight decreased	6.2% 4/64 • Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.

Additional Information

Clinical Development

Byondis B.V.

Phone: 0031246795101

Email: clinicaltrials@byondis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI agrees to provide to the Sponsor 60 days prior to intended submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The Sponsor has the right to review and comment with respect to publications, abstracts, slides, and manuscripts including the data analysis and presentation. In case of disagreement, efforts will be undertaken to resolve any such issues, but the ultimate decision remains with the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER