180 Participants NeededMy employer runs this trial

Givastomig + Nivolumab + Chemotherapy for Stomach Cancer

Recruiting at 6 trial locations
IU
Overseen ByI-MAB US Clinical Trials
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding givastomig to standard treatments can more effectively treat stomach and esophageal cancer. Researchers aim to determine if givastomig can extend the time patients live without their cancer worsening and to identify any side effects it may cause. The trial is open to individuals with advanced or metastatic stomach or esophageal cancer, provided their cancer cells have specific proteins and they have not received certain other treatments. Participants will receive treatments every few weeks and undergo regular check-ups and scans to monitor progress. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study doctors to understand any potential interactions or requirements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that givastomig, when combined with nivolumab and chemotherapy, is generally well-tolerated. In earlier studies, patients tolerated givastomig at doses up to 12 mg/kg every two weeks without major issues. The most common side effects included manageable infusion reactions and some nausea. Another study noted a rare risk of stomach inflammation.

Nivolumab with chemotherapy has also demonstrated safety in other studies. Serious side effects related to the treatment occurred in only a small number of patients. Overall, these findings suggest that the treatment used in this trial has been reasonably safe in humans so far.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine Givastomig, a novel agent, with the existing immunotherapy drug nivolumab and chemotherapy to tackle stomach cancer. Unlike standard treatments that primarily rely on chemotherapy, Givastomig acts by enhancing the body's immune response to target cancer cells more effectively. In the experimental arms, Givastomig is administered in varying doses and schedules, offering potential flexibility and customization in treatment approaches. By integrating this new approach, there's hope for improved outcomes and better management of stomach cancer, sparking significant interest in its potential benefits.

What evidence suggests that this trial's treatments could be effective for stomach cancer?

This trial will evaluate the effectiveness of different combinations of givastomig, nivolumab, and chemotherapy for treating stomach cancer. Studies have shown promising results when combining givastomig with nivolumab and chemotherapy, with 75% of patients experiencing tumor shrinkage or stabilization. The treatment proved even more effective for patients with certain proteins, such as PD-L1 and CLDN18.2. Earlier research found that givastomig was well tolerated and effective against this type of cancer. This evidence suggests that adding givastomig to standard therapy could offer a powerful new option for people with advanced stomach cancer.12467

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic stomach, esophageal, or gastroesophageal junction cancer whose tumors test positive for CLDN18.2 and PD-L1 proteins but are not HER2-positive. Participants must be in good general health, have not had prior treatment for advanced disease, and meet certain organ function requirements.

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
See 7 more

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.
See 12 more

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

Trial Overview

The study compares givastomig (at two possible doses) plus nivolumab and chemotherapy versus nivolumab and chemotherapy alone. Treatments are given by IV every 2-3 weeks to see if adding givastomig helps control the cancer better.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: Givastomig Arm 2 CombinationExperimental Treatment6 Interventions
Group II: Experimental: Givastomig Arm 1 CombinationExperimental Treatment6 Interventions
Group III: Control: Nivolumab Plus ChemotherapyActive Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

I-Mab Biopharma US Limited

Lead Sponsor

Trials
10
Recruited
580+
Headquarters
Rockville, USA
Known For
Precision Medicine
Top Products
TJ202 (Felzartamab), TJ101 (Eftansomatropin), Enoblituzumab

Citations

388MO Preliminary safety and efficacy of givastomig, a ...

Conclusions. Giva with nivolumab and mFOLFOX was well tolerated up to 12 mg/kg Q2W and shows encouraging preliminary activity in 1L metastatic GEC. Dose ...

FDA Type B Meeting Appears Successful for Givastomig in ...

Results from a phase 1b trial for givastomig in frontline HER2-negative, PD-L1–positive gastroesophageal cancer support the FDA's decision.

Nivolumab plus chemotherapy in metastatic gastric cancer ...

Treatment Effectiveness: About 47% of patients showed tumor shrinkage or stable disease. Survival: On average, cancer did not worsen for 5.8 ...

Givastomig Combo Shows Early Promise in CLDN18.2 ...

The combination therapy achieved a 71% objective response rate, with higher efficacy in patients with specific PD-L1 and CLDN18.2 expression ...

NovaBridge Presents Positive Givastomig Dose Expansion ...

Givastomig, a CLDN18.2 x 4-1BB bispecific antibody, continues to show robust efficacy when combined with nivolumab and chemotherapy ...

NovaBridge Presents Positive Givastomig Dose Expansion ...

The safety profile of the combination was similar to earlier observations, except for the emergence of immune-related gastritis, which ...

Dr Klempner on the Safety Profile of Givastomig Plus ...

“The main drug-related adverse effects attributed to givastomig were infusion-related reactions, which are manageable, and some nausea and ...