TJ033721 for Cancer

Recruiting at 21 trial locations

Overseen By US Site Head

Age: 18+

Sex: Any

Trial Phase: Phase 1

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 28 days

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TJ033721 (givastomig) for individuals with advanced or metastatic solid tumors, where the cancer has spread and does not respond to standard treatments. The trial evaluates the safety and tolerance of the treatment, administered alone or with other medications like nivolumab and chemotherapy. Suitable candidates have a solid tumor unresponsive to usual treatments or are receiving treatment for the first time for certain stomach or esophageal cancers. For those with a tumor marked by CLDN18.2, this trial could be an option. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

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

Research has shown that TJ033721, also known as givastomig, is generally safe in early studies. When tested alone in patients with advanced solid tumors, it demonstrated a tolerable safety profile, with side effects remaining manageable even as doses increased.

Givastomig, when combined with nivolumab and chemotherapy, also appeared safe. This combination was tested at various dose levels without reaching a point where side effects became too severe.

Overall, early findings suggest that givastomig, whether used alone or with other treatments, is generally well-tolerated in patients with advanced cancer. However, as these findings are based on early research, further studies are necessary to confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about TJ033721, also known as givastomig, because it offers a novel approach to cancer treatment by targeting specific mechanisms that are not addressed by standard therapies, like chemotherapy and immunotherapy drugs such as pembrolizumab or nivolumab alone. Unlike traditional options, TJ033721 is designed to be administered at various precise dose levels, which may allow for tailored treatment regimens that optimize effectiveness and minimize side effects. Furthermore, TJ033721 can be combined with nivolumab and chemotherapy, potentially enhancing the overall treatment efficacy by leveraging multiple mechanisms of action against cancer cells. This combination approach and dosing flexibility represent a significant advancement in the potential for personalized cancer care.

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

Research has shown that TJ033721, also known as givastomig, may help treat advanced cancers. In earlier studies, givastomig alone shrank tumors in 18% of patients. In this trial, some participants will receive givastomig alone, while others will receive it with nivolumab and chemotherapy. Specifically, when givastomig was combined with nivolumab and chemotherapy, 71% of patients experienced tumor shrinkage. This suggests that adding givastomig to other cancer treatments might enhance their effectiveness. These early results indicate that givastomig could be a valuable option for patients with advanced solid tumors. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• TJ033721

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 OAK study involving 850 patients with advanced non-small cell lung cancer (NSCLC), atezolizumab treatment continued to provide overall survival benefits even after disease progression, with a median post-progression survival of 12.7 months for those who continued treatment.

Atezolizumab was found to have a favorable safety profile, with no increased risks associated with continuing treatment beyond progression, and 49% of patients experienced stable disease, indicating potential ongoing benefits even after traditional measures of progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab Treatment Beyond Progression in Advanced NSCLC: Results From the Randomized, Phase III OAK Study. Gandara, DR., von Pawel, J., Mazieres, 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]

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]

Citations

1.

imab.gcs-web.com

imab.gcs-web.com/news-releases/news-release-details/i-mab-presents-positive-givastomig-phase-1b-dose-escalation-data

I-Mab Presents Positive Givastomig Phase 1b Dose ...

The Phase 1b data (NCT04900818) show a confirmed objective response rate (ORR) of 71% across all doses (12/17), and 83% (10/12) at doses ...

2.

onclive.com

onclive.com/view/dr-klempner-on-data-for-givastomig-plus-nivolumab-mfolfox-in-metastatic-gastric-esophageal-and-gej-adenocarcinoma

Dr Klempner on Data for Givastomig Plus Nivolumab ...

Klempner, MD, discusses the safety and efficacy of givastomig plus nivolumab and chemotherapy in metastatic gastric cancers.

3.

clin.larvol.com

clin.larvol.com/trial-detail/NCT04900818

Study of TJ033721 (givastomig) in Subjects with Advanced ...

"Updated Phase 1 givastomig monotherapy data show an impressive 18% ORR in metastatic gastric cancer patients who had received at least two prior lines of ...

4.

i-mabbiopharma.com

i-mabbiopharma.com/news-releases/news-release-details/i-mab-announces-publication-givastomig-monotherapy-data-clinical

I-Mab Announces Publication of Givastomig Monotherapy ...

Givastomig monotherapy demonstrated an ORR of ~18% in heavily pre-treated gastric cancer patients, across a wide range of Claudin 18.2 ...

5.

withpower.com

withpower.com/trial/phase-1-adenocarcinoma-5-2021-a50d0

TJ033721 for Cancer · Recruiting Participants for Phase ...

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.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04900818

Study of TJ033721 (givastomig) in Subjects with Advanced ...

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 ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40586719/

A First-in-Human Study of Givastomig, a CLDN18.2 and 4- ...

Givastomig demonstrated manageable safety, dose-proportional exposure, and antitumor activity in patients with advanced solid tumors, particularly in CLDN18.2- ...