KSQ-004EX for Advanced Solid Tumors

Overseen By Rodabe N Amaria, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Aminoglycosides, Penicillin, Steroids, others

Disqualifiers: Autoimmune disorders, Brain metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

141 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase 1 is to find the recommended dose of KSQ-004EX to give to participants with advanced solid tumors. Phase 2 is to learn if KSQ-004EX at the recommended dose found in Phase1 can help to control advanced solid tumors. The safety and effects of KSQ-004EX will also be studied in both phases.

Do I need to stop my current medications to join the trial?

The trial requires a 'washout period' (time without taking certain medications) from prior cancer treatments before starting the study. This includes a minimum of 7 days or 5 half-lives for targeted therapies, 21 days or 5 half-lives for monoclonal antibodies, and 21 days or 5 half-lives for chemotherapy. Please discuss with your doctor to understand how this applies to your current medications.

Research Team

Rodabe N. Amaria

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with advanced solid tumors who have not responded to standard treatments. Participants must be adults with measurable disease, adequate organ function, and no autoimmune diseases or conditions that suppress the immune system.

Inclusion Criteria

Washout period from prior anticancer therapy

My head or neck cancer has returned or spread and was treated before.

My bone marrow is working well.

Exclusion Criteria

I am on a stable dose of steroids.

I have a narrowed artery in my neck and a history of heavy smoking.

I am not pregnant or nursing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Evaluate the safety and tolerability of KSQ-004EX and determine the expansion dose in participants with advanced solid tumors

6 months

Phase 2: Expansion

Assess the anti-tumor activity of KSQ-004EX at the recommended dose in participants with advanced malignant solid tumors

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• KSQ-004EX

Trial Overview The study is testing KSQ-004EX, a therapy using patient's own immune cells modified to target cancer. Phase 1 determines the safe dose; Phase 2 checks if this dose can control tumor growth. Fludarabine and Cyclophosphamide are given before KSQ-004EX to prepare the body.

Participant Groups

Group I: Phase 1/Phase 2: Treatment with Lymphodepletion and KSQ-004EX Experimental Treatment 3 Interventions

Participants will receive KSQ-004EX and pre-medicated with cyclophosphamide and fludarabine to prevent the lymphodepletion of the chemotherapy.

Group II: Phase 1 mLDC: Treatment with Modified Lymphodepletion and KSQ-004EX Experimental Treatment 3 Interventions

Participants will receive KSQ-004EX and pre-medicated with cyclophosphamide and fludarabine to prevent the lymphodepletion of the chemotherapy.

Group III: Backfill IL-2: Treatment with Lymphodepletion and KSQ-004EX + IL-2 Experimental Treatment 4 Interventions

Participants will receive KSQ-004EX and pre-medicated with cyclophosphamide and fludarabine to prevent the lymphodepletion of the chemotherapy.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

KSQ Therapeutics, Inc.

Industry Sponsor

Trials

3

Recruited

410+