What side effects are associated with this type of intervention?

Common treatments for stomach cancer, including chemotherapy agents like trifluridine/tipiracil and targeted therapies such as ramucirumab, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, diarrhea, fatigue, and myelosuppression (decreased production of blood cells). Targeted therapies, which inhibit specific molecules involved in cancer growth, can lead to hypertension, proteinuria (excess protein in urine), and gastrointestinal perforations. Both types of treatments may also cause general side effects like loss of appetite and weight loss.

What prior FDA approvals exist?

For the treatment of advanced or metastatic stomach cancer, the FDA has approved several targeted therapies and angiogenesis inhibitors. Ramucirumab, an angiogenesis inhibitor, was approved based on the REGARD and RAINBOW trials, showing improved progression-free and overall survival in combination with paclitaxel. Another drug, apatinib, a VEGFR-2 inhibitor, is approved in China but not in the United States or Europe. Regorafenib, an inhibitor of multiple angiogenic pathways, has also shown activity in advanced gastric cancer. These drugs represent the class of therapies that target tumor growth and angiogenesis, similar to those likely being studied in the TJ033721 trial.

What other types of research exist?

One promising alternative is the use of phage-displayed polypeptides that specifically bind to gastric cancer cells with high metastatic potential to the peritoneum, such as the peptides TLNINRLILPRT and SMSI(X)SPYI(XXX). These peptides have shown specificity in binding to gastric cancer cell variants and may offer a targeted therapeutic approach. Further research is needed to confirm their efficacy in blocking metastasis in vivo.

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TJ033721 for Cancer

Phase 1

Recruiting

Research Sponsored by I-Mab Biopharma US Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay

Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)

Must not have

Prior exposure to 4-1BB agonists

Diagnosis of immunodeficiency such as known active HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 days post last dose

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects aren't detailed here but typically include reactions at the injection site, fatigue, nausea, immune-related issues like inflammation in organs due to the drug targeting certain proteins on cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is CLDN18.2 positive.

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

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I am mostly active and my organs work well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with an immune system disorder like HIV.

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I am currently receiving treatment for an infection through injections or IV.

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I have been treated with CLDN18.2-targeted therapy before.

Select...

I do not have active or chronic Hepatitis B or C.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I have or had lung inflammation that needed treatment.

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I have not had serious heart or blood vessel problems in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days post last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 days post last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days post last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of AEs

Maximum tolerated or administered dose (MTD, MAD)

Secondary study objectives

Pharmacokinetic (PK) Parameters: AUCt

Pharmacokinetic (PK) Parameters: AUC∞

Pharmacokinetic (PK) Parameters: Cmax

+2 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TJ033721 in combination with nivolumab and chemotherapyExperimental Treatment1 Intervention

TJ033721 will be administered in combination with nivolumab and chemotherapy

Group II: TJ033721Experimental Treatment1 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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stomach cancer include targeted therapies, immune checkpoint inhibitors, and chemotherapy. Targeted therapies, such as trastuzumab, work by specifically targeting and inhibiting the function of proteins like HER2 that promote cancer cell growth. Immune checkpoint inhibitors, such as those targeting PD-L1, enhance the body's immune response against cancer cells by blocking proteins that suppress immune activity. Chemotherapy uses drugs to kill rapidly dividing cancer cells or inhibit their growth. These treatments are crucial for stomach cancer patients as they offer more personalized and effective options, potentially improving outcomes and reducing side effects compared to traditional treatments.

AMPKα modulation in cancer progression: multilayer integrative analysis of the whole transcriptome in Asian gastric cancer.Topoisomerase IIalpha gene amplification in gastric carcinomas: correlation with the HER2 gene. An immunohistochemical, immunoblotting, and multicolor fluorescence in situ hybridization study.Pathogenesis and treatment of gastric carcinoma: "an up-date with brief review".