TJ033721 for Cancer

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: I-Mab Biopharma US Limited

Must not be taking: Steroids, Anti-PD-1, PD-L1

Disqualifiers: Hepatitis, Autoimmune, Heart failure, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called TJ033721 to see if it is safe and effective for people with advanced or metastatic solid tumors. The study will look at how the drug behaves in the body and its potential side effects. The goal is to find out if this drug can help treat severe cancer cases.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug TJ033721 for cancer?

The research on similar drugs like tislelizumab and atezolizumab, which are also immune checkpoint inhibitors, shows they can improve overall survival in patients with advanced non-small cell lung cancer when compared to traditional chemotherapy. This suggests that TJ033721, if it works similarly, might also be effective in treating cancer.

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Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors, including stomach and esophageal cancers, who have no standard treatment options left. They must be relatively healthy (ECOG status 0 or 1), have CLDN18.2-positive tumor expression, known PD-L1 status, and adequate organ function.

Inclusion Criteria

My tumor is CLDN18.2 positive.

My cancer's PD-L1 status is known from previous testing.

I am mostly active and my organs work well.

Exclusion Criteria

I have not had any stomach ulcers or bleeding in the last 6 weeks.

I have not had cancer, except for certain skin or cervical cancers, in the last 3 years.

I have been treated with 4-1BB agonists before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TJ033721 (givastomig) at various dose levels, with some receiving it in combination with nivolumab and chemotherapy

28 days

Bi-weekly or every 3 weeks dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and pharmacokinetic parameters

Up to 100 days post last dose

Participant Groups

The study tests TJ033721's safety and effectiveness in patients with specific types of cancer. It's an early-phase trial where everyone gets the drug to see how well it works and what dose is best.

Group I: TJ033721 (givastomig) in combination with nivolumab and chemotherapy Experimental Treatment 1 Intervention

TJ033721 will be administered in combination with nivolumab and chemotherapy

Group II: TJ033721 (givastomig) Experimental Treatment 1 Intervention

Dose Escalation: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi weekly (Q2W) and 1 dose level (18 mg/kg) every 3 weeks (Q3W) During dose expansion, TJ033721 will be administered Q2W, starting at the RP2D or MTD in dose escalation.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dana Farber Cancer Institute Boston, MA

UW Carbone Cancer Center Madison, WI

Beth Israel Deaconess Medical Center Boston, MA

Horizon Oncology Research, LLC. Lafayette, IN

More Trial Locations

Who Is Running the Clinical Trial?

I-Mab Biopharma US Limited Lead Sponsor

I-Mab Biopharma Co. Ltd. Lead Sponsor

Bristol-Myers Squibb Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Examining the Impact of Tislelizumab Added to Chemotherapy on Health-Related Quality-of-Life Outcomes in Previously Untreated Patients With Nonsquamous Non-Small Cell Lung Cancer. [2022] This study assessed the effects of tislelizumab, a programmed cell death protein 1 inhibitor, in combination with chemotherapy versus chemotherapy alone as first-line treatment on health-related quality of life (HRQoL) in patients with advanced nonsquamous non-small cell lung cancer (nSQ-NSCLC).

2. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab Treatment Beyond Progression in Advanced NSCLC: Results From the Randomized, Phase III OAK Study. [2019] Cancer immunotherapy may alter tumor biology such that treatment effects can extend beyond radiographic progression. In the randomized, phase III OAK study of atezolizumab (anti-programmed death-ligand 1) versus docetaxel in advanced NSCLC, overall survival (OS) benefit with atezolizumab was observed in the overall patient population, without improvement in objective response rate (ORR) or progression-free survival (PFS). We examine the benefit-risk of atezolizumab treatment beyond progression (TBP).

3. United States pubmed.ncbi.nlm.nih.gov

Prognostic value of Thyroid Transcription Factor-1 expression in lung adenocarcinoma in patients treated with anti PD-1/PD-L1. [2022] Anti-PD1/PD-L1-directed immune checkpoint inhibitors are game changers in advanced non-small-cell lung cancer, but biomarkers are lacking. The aim of our study was to find clinically relevant biomarkers of the efficacy of ICI in non-squamous NSCLC. We conducted a retrospective study of patients receiving ICI for advanced non squamous NSCLC in two cohorts. For a subset of patients, RNAseq data were generated on tumor biopsy taken before ICI. The primary end point was progression-free survival under ICI. Secondary end point was overall survival from ICI initiation. In the cohort, we studied 231 patients. Clinico-pathological characteristics included KRAS mutant status (n = 88), TTF1-positive expression (n = 136), LIPI (Lung Immune Prognostic Index) score of 0 (n = 116). In our cohort, lack of TTF1 expression, LIPI score >0, line of treatment >1, and liver metastases were associated with poorer PFS. TTF1 and PD-L1 status could be used to stratify survival and improve the AUC for prediction of prognosis in comparison with the PD-L1 gold standard. Using an external cohort of 154 patients, we confirmed the independent prognostic role of TTF1. TTF1 expression and PD-L1 can be used to stratify risk and predict PFS and OS in patients treated with ICI for NS-NSCLC.

4. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non-Small-cell Lung Cancer. [2019] The randomized phase III OAK (a study of atezolizumab compared with docetaxel in participants with locally advanced or metastatic non-small-cell lung cancer [NSCLC] who have failed platinum-containing therapy) trial investigated the anti-programmed cell death ligand 1 (PD-L1) antibody atezolizumab for advanced or metastatic, previously treated, NSCLC. Atezolizumab significantly improved overall survival (OS) compared with docetaxel (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.62-0.87; P = .0003; median OS, 13.8 vs. 9.6 months, respectively). Patient-reported outcomes (PROs) were collected to evaluate disease-related symptoms and health-related quality of life (HRQoL) to support the finding of a survival benefit.

5. United States pubmed.ncbi.nlm.nih.gov

Tislelizumab Versus Docetaxel in Patients With Previously Treated Advanced NSCLC (RATIONALE-303): A Phase 3, Open-Label, Randomized Controlled Trial. [2023] The phase 3 RATIONALE-303 trial (NCT03358875) investigated the efficacy and safety of tislelizumab versus docetaxel in pretreated patients with advanced NSCLC. Here, we report the efficacy and safety results and describe the exploratory biomarker analyses.