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Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies

NCT ID: NCT04672434

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2024-11-22

Brief Summary

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The primary purpose of this study is to see if Sym024 is safe and tolerable as monotherapy and in combination with Sym021 in patients with solid tumor malignancies.

Detailed Description

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Part 1 of this study will assess the safety and tolerability to establish the maximum tolerated dose (MTD) (or the maximum administered dose \[MAD\]) and/or the selected dose(s) of Sym024 in patients with solid tumor malignancies.

Part 2 of this study will assess the safety and tolerability to establish the MTD (or the MAD) and/or the selected dose(s) of Sym024 when administered in combination with Sym021 in patients with solid tumor malignancies.

Part 2a of this study will assess the safety and tolerability of Sym024 when first administered as a single agent during Cycle 1 (safety lead-in) followed by administration in combination with Sym021 during Cycle 2 and subsequent cycles.

Part 3 of this study will assess the safety of Sym024 when administered alone or in combination with Sym021 in expanded cohorts of patients with solid tumor malignancies.

April 2024: The above was the study design at trial start. Per protocol, implementation of a part 3 would require an amendment. However, this was never done as it was decided not to include a part 3.

Conditions

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Metastatic Cancer Solid Tumor

Keywords

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Locally advanced/unresectable Metastatic solid tumor Anti-PD-1 PD-1 PD1 CD73 Squamous cell carcinoma of the head and neck (SCCHN) Non-small-cell lung carcinoma-adenocarcinoma histology subtype (NSCLC-Adeno) Pancreatic ductal adenocarcinoma (PDAC) Cholangiocarcinoma (CCA) Colorectal carcinoma (CRC) Gastric carcinoma (GC) Esophageal carcinoma (EsoCA) Mesothelioma (Meso) Sym021 Sym024 Head and neck squamous cell carcinoma (HNSCC) Cervical carcinoma (CC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sym024 Dose Level 1

Part I, Sym024 monotherapy dose level 1

Group Type EXPERIMENTAL

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Sym024 Dose Level 2

Part I, Sym024 monotherapy dose level 2

Group Type EXPERIMENTAL

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Sym024 Dose Level 3

Part I, Sym024 monotherapy dose level 3

Group Type EXPERIMENTAL

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Sym024 Dose Level 4

Part I, Sym024 monotherapy dose level 4

Group Type EXPERIMENTAL

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Sym024 Dose Level -1

Part I, Sym024 monotherapy dose level -1. Evaluate only if needed based on tolerability

Group Type EXPERIMENTAL

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Sym021+Sym024 Dose Level 2

Part II, Sym021 in combination with dose level 2 of Sym024

Group Type EXPERIMENTAL

Sym021

Intervention Type DRUG

Sym021 is a humanized anti-PD-1 antibody.

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Sym021+Sym024 Dose Level 3

Part II, Sym021 in combination with dose level 3 of Sym024

Group Type EXPERIMENTAL

Sym021

Intervention Type DRUG

Sym021 is a humanized anti-PD-1 antibody.

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Sym021+Sym024 Dose Level 4

Part II, Sym021 in combination with dose level 4 of Sym024

Group Type EXPERIMENTAL

Sym021

Intervention Type DRUG

Sym021 is a humanized anti-PD-1 antibody.

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Sym021+Sym024 Dose Level 5

Part IIa, Sym024 monotherapy and in combination with Sym021

Group Type EXPERIMENTAL

Sym021

Intervention Type DRUG

Sym021 is a humanized anti-PD-1 antibody.

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Sym021+Sym024 Dose Level 1

Part II, Sym021 in combination with dose level 1 of Sym024. Evaluate only if needed based on tolerability

Group Type EXPERIMENTAL

Sym021

Intervention Type DRUG

Sym021 is a humanized anti-PD-1 antibody.

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Dose Expansion Sym021 (+Sym024)

Part III, dose expansion Sym024 and/or Sym021+Sym024

Group Type EXPERIMENTAL

Sym021

Intervention Type DRUG

Sym021 is a humanized anti-PD-1 antibody.

Sym024

Intervention Type DRUG

Sym024 is an anti-CD73 antibody.

Interventions

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Sym021

Sym021 is a humanized anti-PD-1 antibody.

Intervention Type DRUG

Sym024

Sym024 is an anti-CD73 antibody.

Intervention Type DRUG

Other Intervention Names

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Anti-PD-1

Eligibility Criteria

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Inclusion Criteria

* Male or female patients, ≥18 years.
* Documented (histologically or cytologically proven), locally advanced or metastatic solid tumor malignancy (must be one of the following):

1. Squamous cell carcinoma of the head and neck
2. Non-small-cell lung carcinoma-adenocarcinoma histology subtype
3. Pancreatic ductal adenocarcinoma
4. Cholangiocarcinoma
5. Colorectal carcinoma (microsatellite stable \[MSS\] and microsatellite instability-high \[MSI-H\] phenotypes)
6. Gastric carcinoma (includes gastroesophageal carcinoma)
7. Esophageal carcinoma (includes squamous cell and adenocarcinoma)
8. Mesothelioma (pleural and peritoneal)
9. Cervical carcinoma (CC) (includes adeno, squamous and mixed adeno-squamous carcinoma histology subtypes)
* Malignancy that is not currently amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
* Measurable disease according to RECIST v1.1.
* Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit.
* Agreeing to mandatory tumor tissue biopsies (2 total).
* ECOG PS of 0 or 1.
* Adequate organ function as indicated by the following laboratory values.
* Adequate contraception required as appropriate.

Exclusion Criteria

* Central nervous system (CNS) malignancies.
* Clinically significant cardiovascular disease or condition.
* Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study drug(s).
* Active uncontrolled bleeding or a known bleeding diathesis.
* Significant ocular disease or condition.
* Significant pulmonary disease or condition.
* Current or recent (within 6 months) significant gastrointestinal disease or condition.
* Active, known or suspected autoimmune disease.
* History of organ transplantation (i.e., stem cell or solid organ transplant).
* Known history of human immunodeficiency virus (HIV) or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Any other serious/active/uncontrolled infection.
* History of significant toxicities associated with previous administration of immune checkpoint inhibitors.
* Known or suspected hypersensitivity to any of the excipients of formulated study drug.
* Unresolved \>Grade 1 toxicity associated with any prior antineoplastic therapy.
* Inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to the first dose of study drug(s).
* Any other serious, life-threatening, or unstable preexisting medical condition (aside from the underlying malignancy).

Therapeutic Exclusions

* Prior therapy with Sym024 or other inhibitors of CD73, CD39 or adenosine receptors ADORA2A, ADORA2B.
* Part II and Part III, prior anti-PD-(L)1 therapy, except for indications where it is approved.
* Any antineoplastic agent for the primary malignancy (standard or investigational) within 4 weeks or 5 elimination half-lives.
* Any other investigational treatments within 2 weeks prior to the first dose of study drug(s).
* Radiotherapy, with exceptions.
* Live vaccines against infectious diseases 4 weeks prior to the first dose of study drug(s).
* Immunosuppressive or systemic glucocorticoids therapy (\>10 mg daily prednisone or equivalent) within 2 weeks prior to the first dose of study drug(s), with exceptions.
* Prophylactic use of hematopoietic growth factors within 1 week prior to the first dose of study drug(s).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Symphogen A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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N. Lakhani, MD PhD

Role: PRINCIPAL_INVESTIGATOR

START Midwest, USA

Locations

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START Midwest

Grand Rapids, Michigan, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

NEXT Oncology

San Antonio, Texas, United States

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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Sym024-01

Identifier Type: -

Identifier Source: org_study_id