First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2023-12-19

Brief Summary

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

The purpose of this study will be to determine the Maximum Tolerated Dose (MTD) and describe dose-limiting toxicities (DLTs) of W0180 given as monotherapy and in combination with pembrolizumab (anti-PD-1).

Related Clinical Trials

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

A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies

NCT05753722

Advanced or Metastatic Solid Tumors Non Small Cell Lung Cancer NSCLC

RECRUITING PHASE1

Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.

NCT05547321

Advanced Solid Tumor

RECRUITING PHASE1

Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

NCT06234397

Advanced or Metastatic Solid Tumors

RECRUITING PHASE1

A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors

NCT03797391

Neoplasms Neoplasm Metastasis Non-Small-Cell Lung Cancer

RECRUITING PHASE1/PHASE2

Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients With Selected Advanced or Metastatic Solid Tumors

NCT05479812

Metastatic Solid Tumor Advanced Solid Tumor

ACTIVE_NOT_RECRUITING PHASE1

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.

Locally Advanced or Metastatic Solid Tumors

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.

Monotherapy dose escalation: W0180

Participants will receive W0180 in a 21-day cycle until the maximum tolerated dose (MTD)/ recommended dose for expansion (RDE) for the single-agent identified.

Group Type EXPERIMENTAL

W0180

Intervention Type BIOLOGICAL

Participants will receive W0180 in a 21-day cycle.

Combination dose escalation: W0180+Pembrolizumab

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) followed by W0180 in a 21-day Cycle until the MTD in combination is identified or an RDE in combination is established.

Group Type EXPERIMENTAL

W0180

Intervention Type BIOLOGICAL

Participants will receive W0180 in a 21-day cycle.

Pembrolizumab

Intervention Type DRUG

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.

Dose expansion

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion Q3W followed by an RDE dose of W0180 in a 21-day cycle.

Group Type EXPERIMENTAL

W0180

Intervention Type BIOLOGICAL

Participants will receive W0180 in a 21-day cycle.

Pembrolizumab

Intervention Type DRUG

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.

Interventions

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

W0180

Participants will receive W0180 in a 21-day cycle.

Intervention Type BIOLOGICAL

Pembrolizumab

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.

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 diagnosis of locally advanced or metastatic solid tumors, whose disease has progressed or for whom no further standard therapy is available or appropriate
* Evidence of measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (or modified RECIST 1.1 for mesothelioma)
* Adequate blood counts at baseline
* Adequate liver function at screening and baseline
* Sexually active participants must use medically acceptable methods of contraception during the course of this study

Exclusion Criteria

* Participants previously treated with an anti-V-domain Ig suppressor of T cell activation (VISTA) (small molecule or antibody) agent
* Participants with known central nervous system (CNS) metastases and/or carcinomatous meningitis
* History of severe hypersensitivity reactions to other monoclonal antibodies
* Positive for hepatitis B virus(HBV), hepatitis C virus (HCV) or HIV infection
* History of anti-cancer therapies within the last 4 weeks (or \<=5 half-lives for targeted agents) prior to initiating study treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No