Givastomig for Advanced or Metastatic Solid Tumors

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

Recruiting Phase 1 Interventional Study
Solid Tumor Advanced Cancer Metastatic Cancer Gastric Cancer Gastroesophageal Junction Carcinoma Esophageal Adenocarcinoma PDAC - Pancreatic Ductal Adenocarcinoma Biliary Tract Cancer (BTC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
330 (estimated)
Sponsor
I-Mab Biopharma US Limited · Industry
Who this trial is looking for

This trial is looking for people with advanced or metastatic solid tumors who have not responded to standard treatments or do not have other options available. Participants will receive the drug Givastomig to evaluate its safety and effectiveness.

Are You a Good Fit for This Trial?
Rules you out Active autoimmune diseaseActive interstitial lung diseaseKnown active CNS metastasesImmunodeficiency

You may be able to join if

  • I have advanced or metastatic solid tumor cancer.
  • My cancer has progressed despite standard therapy.
  • I have no further standard therapy options.
  • I am treatment naïve for my specific type of cancer.
  • I have a CLDN18.2-positive tumor.
  • I have been tested for PD-L1 status.

You may not be able to join if

  • I have had prior exposure to CLDN18.2-targeted therapy.
  • I have had prior exposure to 4-1BB agonists.
  • I have had another cancer in the last 3 years, except for certain skin cancers.
  • I have known active Hepatitis B or C.
  • I have had digestive tract bleeding or ulcers recently.
  • I have an active autoimmune disease that needs treatment.
  • I have known active brain metastases.
  • I have had severe heart problems in the last 6 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Part 1 - Monotherapy Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options. Part 2 - Combination Therapy Subjects …
Contacts

Clinical Development

(240) 745-6330

us.info@imabbio.com

CONTACT