Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: I-Mab Biopharma US Limited

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.

Research Team

Claire Xu, MD, PhD

Principal Investigator

I-Mab Biopharma

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Inclusion Criteria

You have advanced cancer that has come back or hasn't responded to previous treatments.

Part 2 with Rituximab: Participants with diffuse large B-cell lymphoma (DLBCL) or Indolent B-cell Lymphoma, with at least one measurable lesion by Lugano and available fresh metastatic biopsy sample prior to study entry.

Part 2 with Pembrolizumab: Participants with locally advanced non-small-cell lung carcinoma (NSCLC) with disease progression or immune-oncology treatment naive Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by Response Elevation Criteria in Solid Tumors (RECIST) 1.1, and available fresh metastatic biopsy prior to study entry.

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Exclusion Criteria

Participants with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. Participants who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study.

Participants with Burkitt's lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma.

Participants with mantle cell lymphoma.

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Treatment Details

Interventions

TJ011133 (Unknown)

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Part 2 - Dose ExpansionExperimental Treatment3 Interventions

30 participants (with DLBCL or indolent lymphoma) in the TJ011133 combination therapy with rituximab expansion and 20 participants with solid tumors in the TJ011133 combination therapy with pembrolizumab expansion.

Group II: Part 1C - Combination therapy of TJ011133 with rituximabExperimental Treatment2 Interventions

TJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab.

Group III: Part 1B - Combination therapy of TJ011133 with pembrolizumabExperimental Treatment2 Interventions

TJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab.

Group IV: Part 1A - TJ011133 MonotherapyExperimental Treatment1 Intervention

TJ011133 alone will be administered at up to 7 dose levels (0.3, 1, 3, 10, 20, 30, 45 mg/kg) once weekly (Q1W) (the 0.3 mg/kg dose level cohort will be enrolled if a DLT in 1 out of 3 subjects is observed following the 1 mg/kg dose level).