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Monoclonal Antibodies

TST001 for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Mabspace Biosciences (Suzhou) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors
Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months, until disease progression or start of another anti-cancer therapy
Awards & highlights

Study Summary

This trial is testing a new antibody against various types of cancer.

Who is the study for?
Adults with advanced solid tumors, including stomach, gastroesophageal junction, and pancreatic cancers. Participants must have tried standard treatments without success or be unable to tolerate them. They should be in good physical condition (ECOG PS: 0-1) and not have severe heart disease, recent strokes or heart attacks, active infections like hepatitis B/C or HIV/AIDS.Check my eligibility
What is being tested?
TST001 is being tested alone or with other cancer drugs (Nivolumab or standard care chemotherapies) for safety and effectiveness against certain advanced cancers. This trial includes different patient groups based on prior treatment history and specific cancer types.See study design
What are the potential side effects?
Potential side effects include allergic reactions to TST001 or similar medications, infusion-related reactions from Nivolumab injection, as well as common chemotherapy side effects such as fatigue, nausea, hair loss from Albumin-Bound Paclitaxel; nerve damage may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is advanced and has been confirmed by lab tests.
Select...
I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months, until disease progression or start of another anti-cancer therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months, until disease progression or start of another anti-cancer therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD or Recommended Phase 2 Dose (RP2D)
Participant Safety and Tolerability of TST001 in combination with Nivolumab and mFOLFOX6 as characterized by frequency and severity of adverse events
Participant Safety and Tolerability of TST001 in combination with Nivolumab as characterized by frequency and severity of adverse events
+2 more
Secondary outcome measures
Duration of Response (DOR)
Immunogenicity
Objective response rate (ORR)
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part B Cohort CExperimental Treatment3 Interventions
Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma.
Group II: Part B Cohort BExperimental Treatment2 Interventions
Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies.
Group III: Part B Cohort AExperimental Treatment3 Interventions
Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma.
Group IV: Part A Q3WExperimental Treatment1 Intervention
Dosed every 3 weeks IV with TST001, starting dose is 3 mg/kg, and multiple dose levels will be tested.
Group V: Part A Q2WExperimental Treatment1 Intervention
Dosed every 2 weeks IV with TST001, starting dose is 1 mg/kg, multiple dose levels will be tested.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Albumin-Bound Paclitaxel
2020
Completed Phase 2
~120
Nivolumab Injection [Opdivo]
2018
Completed Phase 1
~20
mFOLFOX6
2009
Completed Phase 4
~1400
Gemcitabine
2017
Completed Phase 3
~2070
TST001
2022
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Mabspace Biosciences (Suzhou) Co., Ltd.Lead Sponsor
4 Previous Clinical Trials
429 Total Patients Enrolled
Suzhou Transcenta Therapeutics Co., Ltd.Lead Sponsor
7 Previous Clinical Trials
1,474 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,631 Previous Clinical Trials
4,126,518 Total Patients Enrolled

Media Library

TST001 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04396821 — Phase 1 & 2
Cancer Clinical Trial 2023: TST001 Highlights & Side Effects. Trial Name: NCT04396821 — Phase 1 & 2
TST001 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04396821 — Phase 1 & 2
Cancer Research Study Groups: Part B Cohort A, Part B Cohort B, Part B Cohort C, Part A Q3W, Part A Q2W

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on enrollment for this research project?

"To participate in this research, 124 suitable candidates must be found. The trial is occuring at multiple sites such as Yale University of New Haven, Connecticut and Sarah Cannon Research Institute located in Nashville, Tennessee."

Answered by AI

What is the geographic scope of oversight for this experiment?

"Currently, 9 clinical trial sites are running this medical trial. They can be found in New Haven, Nashville and Canton to name a few. To reduce the burden of travel for participants, it is recommended that they find the closest site possible."

Answered by AI

Is this clinical research recruitment open at the present?

"Clinicaltrials.gov currently lists this clinical trial as actively recruiting for participants, with its initial post date being May 28th 2020 and the most recent edit occurring on October 21st 2022."

Answered by AI

What safety assessments have been conducted on TST001?

"The safety of TST001 is rated at 1 due to only preliminary data being available that suggests its efficacy and safety."

Answered by AI

What are the fundamental goals of this trial?

"Bristol-Myers Squibb, the trial sponsor, has reported that Participant Safety and Tolerability of TST001 when combined with Nivolumab will be the primary outcome to measure over a 100 day interval after last dose. Secondary outcomes being assessed include Plasma Concentration vs Time Curve (AUC) changes for participants taking TST001, Maximum Serum Concentration (Cmax), and Duration of Response (DOR)."

Answered by AI

Who else is applying?

What site did they apply to?
Gabrail Cancer Research
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I have had the whopper procedure and chemo. Then had a reoccurrence and started chemo again after it was determined it was non operable. Had to stop chemo mid way thru. I’m hoping I may be a fit for the clinical trial and have at least some hope for a treatment option. Thank you for the consideration.
PatientReceived no prior treatments
~9 spots leftby Jun 2024