Givastomig + Nivolumab + Chemotherapy for Stomach Cancer

Recruiting at 2 trial locations

Overseen By I-MAB US Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: I-Mab Biopharma US Limited

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: HER2-positive tumors, Active autoimmune disease, Significant cardiovascular disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: Up to 108 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are:

* Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer?

* What toxicities do participants experience when taking givastomig?

Participants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part.

Up to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks.

Participants will:

* Visit the study treatment center for infusions and/or check-ups and tests every 1-3 weeks

* Report any changes in their symptoms to their study doctors

* Have scans to check for any changes in their cancer every 8-12 weeks

Are You a Good Fit for This Trial?

Inclusion Criteria

I have not had treatment for advanced or metastatic cancer.

Life expectancy ≥90 days

At least 1 measurable lesion per RECIST v1.1

Exclusion Criteria

I have not had another cancer in the past 3 years, except some skin or cervical cancers.

Participation in another therapeutic clinical trial

I have recently had radiation therapy and have not fully recovered.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive givastomig in combination with nivolumab and chemotherapy or nivolumab and chemotherapy alone. Treatments are administered via intravenous infusion every 2 or 3 weeks.

Up to 108 weeks

Visits every 1-3 weeks for infusions and check-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tumor assessments and adverse event monitoring.

Up to 30 days after last dose

Long-term Follow-up

Participants' progression-free survival and overall survival are monitored.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Givastomig
• Nivolumab

How Is the Trial Designed?

Group I: Experimental: Givastomig Arm 2 Combination Experimental Treatment 6 Interventions

Givastomig (IV) 12 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 18 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX

Group II: Experimental: Givastomig Arm 1 Combination Experimental Treatment 6 Interventions

Givastomig (IV) 8 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 12 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX

Group III: Control: Nivolumab Plus Chemotherapy Active Control 5 Interventions

Nivolumab in combination with modified FOLFOX (mFOLFOX) or CAPOX

Who Is Running the Clinical Trial?

I-Mab Biopharma US Limited

Lead Sponsor

Trials

10

Recruited

580+

Headquarters

Rockville, USA

Known For

Precision Medicine

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