What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as oxaliplatin-based chemotherapy (e.g., FOLFOX), fluorouracil (FU), and capecitabine, are associated with several side effects. Oxaliplatin can cause cumulative sensory neuropathy, which may persist in some patients for years. Fluorouracil is linked to gastrointestinal issues like diarrhea, nausea, and vomiting, as well as stomatitis and fatigue. Capecitabine, an oral prodrug of fluorouracil, can cause hand-foot syndrome, diarrhea, nausea, vomiting, and fatigue. These treatments can also lead to hematologic toxicities such as neutropenia, anemia, and thrombocytopenia.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of colorectal cancer. Notable approvals include cetuximab and panitumumab, which are monoclonal antibodies targeting the epidermal growth factor receptor (EGFR). Additionally, bevacizumab, an anti-VEGF antibody, has been approved for use in combination with chemotherapy. More recently, immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target PD-1, have been approved for microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancers. These treatments are similar in their targeted approach to what is being studied with TST003.

What other types of research exist?

Promising novel alternatives to TST003 for colorectal cancer patients include the combination of capecitabine and bevacizumab, which has shown a high tumor control rate and a median progression-free survival of 23.4 months in a phase II trial. Additionally, immune checkpoint inhibitors combined with other immune-modulating agents are being explored and show early promise, though further studies are needed.

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TST003 for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Suzhou Transcenta Therapeutics Co., Ltd.

Eligibility Criteria Checklist

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

Must have

At least 18 years of age at the time of informed consent.

For Phase 1a Part: Subjects with histological or cytological diagnosed unresectable locally advanced or metastatic solid tumors

Must not have

Prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, or targeted therapy or herbal medicine) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug.

Any unresolved Grade 2 or greater toxicity from previous anticancer therapy except alopecia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests TST003, a new drug for treating advanced cancers. It focuses on patients with advanced or metastatic solid tumors and later specifically on colorectal cancer. The drug is given through a vein, and doctors will monitor its safety, side effects, and effectiveness.

Who is the study for?

Adults with certain advanced solid tumors, measurable lesions (for Phase Ib), and no standard treatment options left. They must be in good general health with proper organ function, not pregnant or nursing, and willing to use contraception. People who've had recent cancer treatments or severe illnesses are excluded.

What is being tested?

TST003 is being tested for safety in cancer patients. The study will determine the safe dosage level, how long it stays in the body, side effects experienced by participants, and if it helps shrink their tumors. It's given intravenously every three weeks as long as benefits continue.

What are the potential side effects?

Specific side effects of TST003 aren't listed but generally may include reactions at the infusion site, fatigue, nausea, blood count changes among others based on similar drugs' profiles; all participants will be closely monitored for any adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have an advanced cancer that cannot be removed by surgery.

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My cancer is advanced, cannot be surgically removed, and tests positive for GREM1.

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My cancer has worsened despite treatment and there are no standard treatments left.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney function is within the required range.

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My liver tests for bilirubin, ALT, and AST are within normal limits.

Exclusion Criteria

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

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I haven't had cancer treatment or herbal medicine in the last 4 weeks or 5 half-lives.

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I don't have any lasting side effects from cancer treatment, except for hair loss.

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I do not have a history of serious lung diseases like pulmonary fibrosis.

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I haven't had serious heart issues or strokes in the last 6 months.

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My heart's electrical activity (QT interval) is longer than normal or I have risk factors for irregular heartbeat.

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I have had serious bleeding in my stomach or intestines in the last 3 months.

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I haven't needed treatment for colitis in the last 4 weeks.

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I have a history of ulcerative colitis or Crohn's disease.

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I do not have any serious infections needing IV treatment.

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I have HIV/AIDS.

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I am not pregnant or nursing.

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I have been treated with a GREM1 targeted therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assess Adverse events (AEs) of TST003

Assess abnormal findings related to TST003

Assess the Dose limiting toxicities of TST003

+6 more

Secondary study objectives

Determine the formation of Anti-drug antibody (ADA) against TST003

Determine the formation of Neutralizing antibodies (NAb) against TST003

To Determine Trough serum concentration of TST003

+2 more

Other study objectives

To assess biomarkers in tumor tissue , and the correlation between biomarkers and PK, pharmacodynamic and clinical outcomes of TST003

To assess biomarkers, in blood and the correlation between biomarkers and PK, pharmacodynamic and clinical outcomes of TST003

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: Phase 1b Part - Dose Expansion at Recommended Phase 2 doseExperimental Treatment1 Intervention

Administer TST003 every 3 weeks to patients with positive GREM1 tumor expression at the recommended Phase 2 Dose,

Group II: Phase 1a Part - TST003 Dose EscalationExperimental Treatment1 Intervention

TST003 administered every 3 weeks at increasing doses 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg

0 / 19Eligibility 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 colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy drugs, such as fluoropyrimidines and oxaliplatin, work by interfering with DNA replication in rapidly dividing cancer cells, leading to cell death. Targeted therapies, like bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis, effectively starving the tumor of nutrients. Immunotherapy, although less common for colorectal cancer, aims to boost the body's immune response against cancer cells. Understanding these mechanisms is crucial for patients as it helps them comprehend how treatments can control tumor growth, manage side effects, and potentially improve their quality of life. In the context of TST003, which is being studied for its safety and efficacy, knowing the mechanism can provide insights into how it might offer clinical benefits and what side effects to anticipate.

Taiwan Society of Colon and Rectal Surgeons Consensus on mCRC Treatment.Proton beam therapy in rectal cancer: A systematic review and meta-analysis.Detecting the Research Trends and Hot Spots in External Irradiation Therapy for Rectal Cancer.