A Phase 1/2 Study of GEN1286 in Patients With Advanced 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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2028-06-29

Brief Summary

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The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in participants with advanced solid tumors.

This trial consists of 2 parts:

* Part A: Dose escalation and dose level expansion
* Part B: Tumor-specific expansion with dose optimization

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Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

No randomization will be performed in Part A (dose escalation- sequential assignment). In Part B (tumor-specific expansion- parallel assignment), participants in each cohort will be randomized with a 1:1 ratio to receive one of the expansion doses of GEN1286.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GEN1286

Group Type EXPERIMENTAL

GEN1286

Intervention Type DRUG

Specified dose on specified days.

Interventions

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GEN1286

Specified dose on specified days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants must be ≥ 18 years of age at the time of informed consent; have measurable disease according to RECIST 1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; adequate organ, bone marrow, liver, coagulation, and renal function; and be willing to provide a pretreatment tumor specimen.
* All participants must have pathologically confirmed diagnosis of advanced solid tumor.
* Participants must have metastatic or unresectable locally advanced, recurrent disease not amenable to further local therapy and must have previously received therapies known to confer clinical benefit (unless ineligible to receive, refused to receive, or therapy is unavailable in the region).