S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2026-03-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations.

\*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

NCT03475953

Colorectal Cancer Not MSI-H or MMR-deficient GIST Oesophageal or Gastric Carcinoma +12 more

RECRUITING PHASE1/PHASE2

Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

NCT05963490

Microsatellite Stable Metastatic Colorectal Cancer

RECRUITING PHASE2

Study With Atezolizumab Plus Bevacizumab in Patients With Chemotherapy Resistant, MSI-like, Colorectal Cancer

NCT02982694

MSI ColoRectal Cancer Chemotherapy +1 more

TERMINATED PHASE2

A Study to Find the Best Dose of BI 905711 in Combination With Chemotherapy and to Test Whether This Dose Helps People With Advanced Gastrointestinal Cancers

NCT05087992

Gastrointestinal Cancer, Metastatic

COMPLETED PHASE1

A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy

NCT02053376

Metastatic Biliary Tract Carcinoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dose escalation 1a: S95029

Group Type EXPERIMENTAL

S095029

Intervention Type DRUG

S095029 will be administered via IV infusion every 2 weeks. Once the DLT evaluations period at the second dose level is completed and it is deemed as safe, the dose escalation part 1b will be initiated.

Dose escalation 1b: S95029 and Sym021

Group Type EXPERIMENTAL

S95029 and Sym021

Intervention Type DRUG

Sym021 will be administered at a fixed dose of 200mg. S095029 will be administered via IV infusion every 2 weeks. Once the RP2D dose of S95029 in combination with Sym21 is defined, dose expansion will begin.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

S095029

S095029 will be administered via IV infusion every 2 weeks. Once the DLT evaluations period at the second dose level is completed and it is deemed as safe, the dose escalation part 1b will be initiated.

Intervention Type DRUG

S95029 and Sym021

Sym021 will be administered at a fixed dose of 200mg. S095029 will be administered via IV infusion every 2 weeks. Once the RP2D dose of S95029 in combination with Sym21 is defined, dose expansion will begin.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies
* Patients with a malignancy not amenable to surgical intervention
* Patients with measurable disease and progression radiologically assessed
* Patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment.
* Patients with available archived tumor biopsy specimens or agree to mandatory biopsy
* Estimated life expectancy ≥ 12 weeks
* Adequate haematological function
* Adequate renal function
* Adequate hepatic function

Exclusion Criteria

* Pregnant and lactating women
* Major surgery within 4 weeks prior to the first IMP administration or not recovered from the surgery
* Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration
* Active Hepatitis B Virus infection
* Carriers of HIV antibodies
* Patients with active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration
* History of organ transplantation
* History of gastrointestinal perforation, or intra-abdominal abscess within 28 days of inclusion
* History of cirrhosis
* History of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition
* Treatment with systemic immunosuppressive therapy
* Active autoimmune disease
* Administration of a live vaccine within 28 days prior to inclusion

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No