TJ033721 for Cancer

Recruiting at 20 trial locations

Overseen By US Site Head

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. ^{1 2 3 4 5}

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

Treatment Details

Interventions

• TJ033721 (Other)

Trial Overview 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.

Participant Groups

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.

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

I-Mab Biopharma Co. Ltd.

Lead Sponsor

Trials

22

Recruited

2,500+

Founded

No information found

Headquarters

Rockville, USA

Known For

Precision Immuno-Oncology

Top Products

TJ202 (Felzartamab), TJ101 (Eftansomatropin), Enoblituzumab, TJ107

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

In a phase III study involving 332 patients with advanced nonsquamous non-small cell lung cancer, the combination of tislelizumab and chemotherapy significantly improved health-related quality of life (HRQoL) scores at week 18 compared to chemotherapy alone, indicating enhanced overall well-being for patients.

Patients receiving tislelizumab plus chemotherapy reported greater reductions in specific symptoms such as coughing, chest pain, and dyspnea, suggesting that this combination therapy not only improves HRQoL but also alleviates key disease-related symptoms.

NCBI (Pubmed)

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. Lu, S., Yu, Y., Barnes, G., et al.[2022]

In a study of 231 patients with advanced non-squamous non-small-cell lung cancer (NSCLC), TTF1 expression and PD-L1 status were identified as important biomarkers that can help predict patient outcomes, specifically progression-free survival (PFS) and overall survival (OS) when treated with immune checkpoint inhibitors (ICIs).

The research found that patients lacking TTF1 expression, having a Lung Immune Prognostic Index (LIPI) score greater than 0, receiving treatment beyond the first line, and those with liver metastases had poorer PFS, highlighting the potential of these biomarkers to guide treatment decisions.

NCBI (Pubmed)

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. Galland, L., Le Page, AL., Lecuelle, J., et al.[2022]

In the phase III OAK trial involving 850 patients with advanced non-small-cell lung cancer, atezolizumab significantly improved overall survival compared to docetaxel, with a median survival of 13.8 months versus 9.6 months.

Atezolizumab also delayed the deterioration of physical and role functions, and showed a trend towards improved health-related quality of life, indicating it may provide better symptom management than docetaxel.

NCBI (Pubmed)

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. Bordoni, R., Ciardiello, F., von Pawel, J., et al.[2019]

In the phase 3 RATIONALE-303 trial involving 805 patients with advanced non-small cell lung cancer (NSCLC), tislelizumab demonstrated a significant improvement in overall survival (OS) compared to docetaxel, with median OS of 17.2 months versus 11.9 months, respectively.

Tislelizumab showed consistent efficacy across different PD-L1 expression levels, and exploratory analyses suggested that certain genetic mutations (NOTCH1-4) may enhance its effectiveness, while no new safety concerns were identified.

NCBI (Pubmed)

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. Zhou, C., Huang, D., Fan, Y., et al.[2023]

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]

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

Atezolizumab Treatment Beyond Progression in Advanced NSCLC: Results From the Randomized, Phase III OAK Study. [2019]

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]

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]

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]