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

NCT06685068 | Terminated Phase 1 FDA Drug

• 3 other identifiers: GCT1286-01CTR20250215PRO1286-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  From first dose until 12 months post last dose of study drug or withdrawal of consent, death, or study closure, whichever occurs first (Up to approximately 3 years 9 months)

• Number of Participants With Dose Limiting Toxicities (DLTs)

  Toxicities will be graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.

  During first cycle (Cycle length=21 days)

Secondary Outcomes (12)

• Objective Response Rate (ORR)

  Up to approximately 3 years 9 months

• Disease Control Rate (DCR)

  Up to approximately 3 years 9 months

• Progression Free Survival (PFS)

  Up to approximately 3 years 9 months

• Duration of Objective Response (DOR)

  Up to approximately 3 years 9 months

• Area Under the Plasma or Serum Concentration Time Curve (AUC) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Total Antibody (Tab) and u-Exatecan

  Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days)

Study Arms (1)

GEN1286

EXPERIMENTAL

Drug: GEN1286

Interventions

GEN1286 DRUG

Specified dose on specified days.

GEN1286

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \- Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy.

Sponsors & Collaborators

• Genmab: lead

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

START San Antonio

San Antonio, Texas, 78229, United States

Location

START Mountain Region

West Valley City, Utah, 84119, United States

Location

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: November 13, 2024
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)