Solid Tumors > IMGC936

IMGC936 for Advanced Solid Cancers

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: ImmunoGen, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a Phase 1/2, first-in-human, open-label, dose-escalation, and expansion study designed to characterize the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of IMGC936 administered by intravenous (IV) infusion.

Eligibility Criteria

This trial is for adults with certain advanced solid tumors who've had limited prior treatments, have acceptable organ function and performance status, and are not pregnant or breastfeeding. They must use effective contraception and cannot have active central nervous system disease, serious heart conditions, uncontrolled infections, or recent major surgeries.

Inclusion Criteria

I have pancreatic cancer and have had 1-3 treatments, with no more than 2 being chemotherapy.

I have had 1 to 3 treatments for colorectal cancer.

My cancer has returned or didn't respond to treatment and no other effective therapy is available.

My white blood cell count is healthy without medication.

My kidney function, measured by eGFR or creatinine clearance, is above 30 mL/min.

I have triple-negative breast cancer and received 1-4 treatments for it after it spread.

I've had 1-4 treatments for NSCLC, with no more than 2 involving chemotherapy.

I am 18 years old or older.

I have had 1 to 3 treatments for my gastroesophageal cancer.

Exclusion Criteria

I do not have an active hepatitis B or C infection.

I have a cytomegalovirus infection.

I do not have severe heart failure.

I do not have serious heart rhythm problems that aren't well-managed with medication.

I do not have ongoing serious eye problems or a history of major eye surgery.

I have had a bone marrow, stem cell, or organ transplant in the past.

I have not had a stroke or mini-stroke in the last 6 months.

I am HIV positive.

I do not need extra oxygen (except for sleep apnea) and have not had severe lung inflammation from drugs or radiation.

I haven't needed IV antibiotics for an infection in the last 2 weeks.

I do not have current pericarditis or significant fluid around my heart.

I currently have myocarditis.

Participant Groups

IMGC936 is being tested in this early-phase study to evaluate its safety and how well it works against advanced solid tumors. Participants will receive the drug through an IV infusion. The study includes initial dose testing followed by a phase where more patients receive the drug to further assess its effects.

Group I: Dose Expansion - TNBC: IMGC936 6.0 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Group II: Dose Expansion - NSCLC: IMGC936 6.0 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Group III: Dose Escalation - Schedule B: IMGC936 2.0 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 2.0 mg/kg on Days 1, 8, and 15 of a 28-day cycle for the first 2 cycles. On all subsequent cycles (Cycle 3 and beyond), participants received IMGC936 2.0 mg/kg on Days 1 and 8 of a 28-day cycle.

Group IV: Dose Escalation - Schedule A: IMGC936 7.0 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 7.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Group V: Dose Escalation - Schedule A: IMGC936 6.0 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Group VI: Dose Escalation - Schedule A: IMGC936 5.0 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 5.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Group VII: Dose Escalation - Schedule A: IMGC936 4.0 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 4.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Group VIII: Dose Escalation - Schedule A: IMGC936 2.0 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 2.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Group IX: Dose Escalation - Schedule A: IMGC936 1.0 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Group X: Dose Escalation - Schedule A: IMGC936 0.5 mg/kg Experimental Treatment 1 Intervention

Participants received IMGC936 0.5 milligrams (mg)/kilogram (kg) via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Stephenson Cancer Center Oklahoma City, OK

Sarah Cannon Research Institute Denver, CO

Florida Cancer Specialists Sarasota, FL

Dana-Farber Cancer Institute Boston, MA

More Trial Locations

Who is running the clinical trial?

ImmunoGen, Inc. Lead Sponsor

MacroGenics Industry Sponsor

References