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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
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).
Are ≥18 years old males or females.
Must not have
Have received chemotherapy, biologic therapy, immunotherapy, radiotherapy (except palliative radiation delivered to <20% of bone marrow), or investigational agents within 4 weeks before the first dose of study drug. Patients who have received targeted therapy (investigational or approved) must not have received their last dose within 4 weeks, or within 5 half-lives (whichever is shorter) prior to treatment with the study drug (Cycle 1, Day 1).
Have any of the following ocular conditions at baseline:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
My ovarian cancer is high grade and not responding to standard treatments.
Select...
I am 18 years old or older.
Select...
My cancer is resistant to standard treatments.
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I have had 8 or fewer previous cancer treatments.
Select...
I have recovered from side effects of previous treatments, except for mild hair loss.
Select...
I am fully active or can carry out light work.
Select...
My advanced cancer does not respond to standard treatments.
Select...
My CD4+ T-cell count is 350 or higher.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had cancer treatments or experimental drugs in the last 4 weeks.
Select...
I have an eye condition.
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I am allergic to taxanes or ingredients in the TH1902 drug.
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My cancer got worse while on or within 6 months after finishing a taxane-based treatment.
Select...
I have ongoing eye problems from treatment that are moderate to severe.
Select...
I need frequent procedures to remove excess fluid from my abdomen.
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I had severe side effects from taxane-based treatment.
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I do not have significant nerve damage or muscle weakness.
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I have ongoing nerve damage symptoms that are moderate or severe.
Select...
I haven't taken drugs that affect liver enzymes in the last 14 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Maximum tolerated dose (MTD) of TH1902.
Recommended Phase 2 Dose (RP2D) of TH1902.
Secondary study objectives
Efficacy in patients
Plasma concentration
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
14 Previous Clinical Trials
639 Total Patients Enrolled
PPD DEVELOPMENT, LPIndustry Sponsor
158 Previous Clinical Trials
35,979 Total Patients Enrolled
TheratechnologiesLead Sponsor
10 Previous Clinical Trials
2,208 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ECG shows a specific measurement called QTc that is longer than 470 milliseconds.You have any of the following blood-related issues before starting the study.I have chronic HBV, a history of HCV, or am on HCV treatment.My ovarian cancer is high grade and not responding to standard treatments.I haven't had cancer treatments or experimental drugs in the last 4 weeks.I have an eye condition.I am 18 years old or older.I agree to use effective birth control methods during and after treatment as required.I do not have any major health issues that could affect my safety or interfere with the study.My cancer is resistant to standard treatments.I have recovered from previous treatment side effects, except for mild nerve issues or hair loss.I have had 8 or fewer previous cancer treatments.You have certain abnormal blood test results at the beginning of the study.Your kidneys do not filter blood well, with a clearance of less than 50 mL/min.I have recovered from side effects of previous treatments, except for mild hair loss.I don't have active brain metastases or spinal issues that could affect my treatment.I agree to use highly effective birth control methods if I'm sexually active.I do not have active brain cancer or spinal issues but can join if my brain cancer has been stable for 4 weeks without steroids.It looks like there might be a mistake here. It seems like the criterion "Part 4" may be incomplete or missing information. If you provide more details or context, I'd be happy to help you summarize it.I am fully active or can carry out light work.I am allergic to taxanes or ingredients in the TH1902 drug.My cancer got worse while on or within 6 months after finishing a taxane-based treatment.I have ongoing eye problems from treatment that are moderate to severe.I need frequent procedures to remove excess fluid from my abdomen.I had severe side effects from taxane-based treatment.I have not received a live vaccine in the last 30 days.I do not have significant nerve damage or muscle weakness.I haven't had a serious infection needing IV treatment in the last 14 days.I have ongoing nerve damage symptoms that are moderate or severe.I haven't taken drugs that affect liver enzymes in the last 14 days.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.My advanced cancer does not respond to standard treatments.I have recovered from side effects of previous treatments, except for mild hair loss.You have a specific amount of disease that can be measured using a standard guideline.People with HIV, Hepatitis B, or Hepatitis C can join the study if they meet certain conditions.I haven't had treatments for advanced lung cancer, but past treatments for early-stage cancer ended over a year ago.My CD4+ T-cell count is 350 or higher.My cancer is not responding to standard treatments and TH1902 could be an option.I have had 8 or fewer cancer treatments in total.
Research Study Groups:
This trial has the following groups:- Group 1: TH1902
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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