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Antibody-Drug Conjugate

TH1902 for Cancer

Phase 1
Recruiting
Led By Funda Meric-Burnstam, MD
Research Sponsored by Theratechnologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The following eligibility criteria are for patients with evidence of chronic HBV infection or patients with history of chronic HCV or who are virologically suppressed on HCV treatment:
Diagnosed with histologically or cytologically confirmed high grade serous ovarian cancer, including high grade peritoneal or fallopian tube, or high grade endometrioid cancer, that is refractory or resistant to standard therapies, not considered platinum sensitive, and where current therapy is not considered to be providing benefit. Patients with clear-cell, mucinous, low grade serous ovarian cancer or carcinosarcoma are not eligible for the study (replaces inclusion criterion #3).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, TH1902, in cancer patients who have few other treatment options. The first part of the trial is to find the best dose of the drug, and the second part is to test it in patients with specific types of cancer that are known to express a protein called SORT1.

Who is the study for?
Adults with advanced solid tumors that have not responded to standard treatments, including chemotherapy and surgery. Participants must be in relatively good health otherwise (ECOG status of 0-1), have a life expectancy of at least 3 months, and measurable disease. Women who can become pregnant and men with partners who can become pregnant must use effective contraception.Check my eligibility
What is being tested?
TH1902 is being tested on patients with various types of cancer such as breast, ovarian, endometrial, skin (melanoma), thyroid, lung (SCLC), prostate cancers and others expressing SORT1. The trial has four parts: dose escalation for all comers; expansion for specific cancers; optimization for high-grade serous ovarian cancer; basket expansion based on earlier results.See study design
What are the potential side effects?
Specific side effects are not listed but may include typical reactions to cancer therapies such as fatigue, nausea, allergic reactions to the drug's components like polysorbate 80 or taxanes if present in TH1902 formulation. Close monitoring will occur due to the experimental nature of this treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic HBV, a history of HCV, or am on HCV treatment.
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My ovarian cancer is high grade and not responding to standard treatments.
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I am 18 years old or older.
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My cancer is resistant to standard treatments.
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I have recovered from previous treatment side effects, except for mild nerve issues or hair loss.
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I have had 8 or fewer previous cancer treatments.
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I have recovered from side effects of previous treatments, except for mild hair loss.
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I agree to use highly effective birth control methods if I'm sexually active.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I am fully active or restricted in physically strenuous activity but can do light work.
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It seems like there might be a mistake, as "Part 3" doesn't provide enough context to rewrite the criterion for clarity. If you can provide more details or the specific criterion you'd like to have rewritten, I'd be happy to help.
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My advanced cancer does not respond to standard treatments.
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I have recovered from side effects of previous treatments, except for mild hair loss.
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I haven't had treatments for advanced lung cancer, but past treatments for early-stage cancer ended over a year ago.
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My CD4+ T-cell count is 350 or higher.
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My cancer is not responding to standard treatments and TH1902 could be an option.
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I have had 8 or fewer cancer treatments in total.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Maximum tolerated dose (MTD) of TH1902.
Recommended Phase 2 Dose (RP2D) of TH1902.
Secondary outcome measures
Efficacy in patients
Plasma concentration

Trial Design

1Treatment groups
Experimental Treatment
Group I: TH1902Experimental Treatment1 Intervention
TH1902 peptide-drug conjugate

Find a Location

Who is running the clinical trial?

Altasciences Company Inc.Industry Sponsor
10 Previous Clinical Trials
357 Total Patients Enrolled
TheratechnologiesLead Sponsor
10 Previous Clinical Trials
2,208 Total Patients Enrolled
PPDIndustry Sponsor
158 Previous Clinical Trials
36,713 Total Patients Enrolled

Media Library

TH1902 (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT04706962 — Phase 1
Small Cell Lung Cancer Research Study Groups: TH1902
Small Cell Lung Cancer Clinical Trial 2023: TH1902 Highlights & Side Effects. Trial Name: NCT04706962 — Phase 1
TH1902 (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04706962 — Phase 1

Frequently Asked Questions

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

What have been the reported outcomes of TH1902 treatments on patients?

"There is minimal evidence that TH1902 is safe and effective, hence it was awarded a score of 1."

Answered by AI

How many participants are there in this experimental research?

"This medical research requires the involvement of 70 patients that adhere to the inclusion criteria. Notably, eligible individuals can partake in this study at START Midwest situated in Grand Rapids, Michigan or at University of Texas MD Anderson Cancer Center based in Houston, Pennsylvania."

Answered by AI

Is this particular clinical study still open to further participants?

"As per the documentation on clinicaltrials.gov, this medical trial is now recruiting participants. It was initially launched in March 2021 and updated as recently as June 2022."

Answered by AI

What is the current count of medical sites executing this clinical trial?

"This clinical trial is currently being conducted in 6 different cities, with Grand Rapids, Houston and Gettysburg constituting 3 of the locations. Therefore it is advised that patients select a clinic nearest to them so they can reduce their travel costs if they decide to join this study."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
Cedars-Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
~13 spots leftby Dec 2024