A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors

STATUS

Recruiting
participants needed

114
sponsor

Mabspace Biosciences (Suzhou) Co., Ltd.

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Updated on 19 February 2024

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cancer

measurable disease

lung cancer

solid tumor

monoclonal antibodies

ovarian cancer

cancer treatment

cancer therapy

solid neoplasm

hair thinning

HER2

pancreatic cancer

Summary

This is an open label Phase 1, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic, colon and lung cancers.

Description

Part A of the trial will consist of two cohorts, one dosed every 2 weeks and one dosed every 3 weeks in a standard 3+3 design. Part A is the dose finding portion of the trial.

27 to 54 participants will be enrolled.

Part B consists of 3 cohorts of approximately 20 participants each. For Part B, participants must have CLDN18.2 expressing tumors to qualify for participation. Cohort 1 is for participants with gastric and gastroesophageal junction cancers and dosed every 2 weeks. Cohort 2 is for participants with solid tumors except gastric and gastroesophageal cancers, dosed every 2 weeks. Cohort 3 is for all solid tumors dosed every 3 weeks. Up to 60 participants will be enrolled.

The trial will last approximately 2 years, with assessments including safety labs, ECGs, MUGA scans, PKs and PDs and CT/MRI tumor assessments, based on the Q2W and Q3W dosing schedules.

Details

Condition	Advanced Cancer
Age	18years - 100years
Treatment	TST001
Clinical Study Identifier	NCT04396821
Sponsor	Mabspace Biosciences (Suzhou) Co., Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Willing and able to provide signed and dated informed consent
	Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors
	Patients must be: a) progressed after standard therapies, b) intolerant of standard therapies, or c) with a tumor type without standard therapy. d) Patients with HER2+ GC/GEJ cancer must have progressed after HER2-targeted therapy
	CLDN18.2 expression in tumor (Part B only): patients with locally advanced or metastatic unresectable GC, GEJ cancer, or other solid tumor including but not limited to pancreatic cancer, cholangiocarcinoma, ovarian cancer, and lung cancer
	Eastern Cooperative Oncology Group Performance Status (ECOG PS): Part A 0~1, Part B 0~2
	Life expectancy 3 months
	At least one measurable lesion per RECIST 1.1 (Part B only)
	Provide archived tumor tissue samples
	Adequate organ function
	Recover to Grade 0-1 from adverse events related to prior anti-cancer therapy except alopecia
Exclusion Criteria
	Symptomatic central nervous system metastases
	Prior anticancer therapy
	Prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, or targeted therapy) within 4 weeks prior to Cycle 1 Day 1, or chemotherapy without delayed toxicity within the last 2 weeks preceding the first dose of study treatment with grade 1 treatment related AEs
	Radiation therapy within 4 weeks prior to Cycle 1 Day 1
	Prior treatment with an anti-CLDN18.2 antibody
	Major surgery within 8 weeks prior to study entry; Minor surgery within 2 weeks prior to study entry
	Gastrointestinal abnormalities including
	Documented unresolved gastric outlet obstruction or persistent vomiting defined as 3 episodes within 24 hours
	Active peptic ulcer disease required treatment in the past 3 months
	Gastrointestinal bleeding as evidenced by hematemesis, hematochezia, or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy
	Documented active colitis within 4 weeks prior to study entry, including infectious colitis, radiation colitis and ischemic colitis
	History of ulcerative colitis or Crohn's disease
	Allergy or sensitivity to TST001 or known allergies to antibodies produced from Chinese hamster ovary cells, which in the opinion of the investigator suggests an increased potential for hypersensitivity to TST001
	History of a Grade 3-4 allergic reaction to treatment with another monoclonal antibody
	Severe cardiovascular disease
	QTc 470ms at baseline
	Concurrent malignancy within 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment (with or without resection), ductal carcinoma in situ of the breast, or T1 urothelial carcinoma
	Prior stem cell, bone marrow or solid organ transplant
	Active infection requiring intravenous therapy within 2 weeks prior to entry
	Women of childbearing potential, unless they are using highly effective methods of contraception during the intervention period and for 90 days after the last dose of study intervention
	Men with a partner of childbearing potential who do not consent to use two highly effective methods of birth control during treatment and for an additional 90 days after the last administration of investigational drug
	Any condition that the investigator or primary physician believes may not be appropriate for participating the study

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A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors