Actively Recruiting
TT-702 in Patients With Advanced Solid Tumours.
Led by Cancer Research UK · Updated on 2024-05-13
188
Participants Needed
3
Research Sites
279 weeks
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
T
Teon Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is evaluating the drug candidate TT-702 in patients with advanced solid tumours. The main aims of the trial are to determine the maximum dose of TT-702 that can be given safely to patients alone and in combination with other anti-cancer agents.
CONDITIONS
Official Title
TT-702 in Patients With Advanced Solid Tumours.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and cooperate with treatment and follow-up
- Willing to provide blood and tissue samples as required
- Consent to access archival tissue and fresh tumor biopsies when feasible
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Aged 16 years or older for TT-702 monotherapy cohorts; 18 years or older for combination with darolutamide
- Blood counts and biochemistry within required ranges
- Measurable disease confirmed by radiology with progression at enrollment
- For metastatic castrate-resistant prostate cancer (mCRPC) patients: castrate testosterone levels (<1.7 nmol/L)
- Phase I dose escalation: advanced solid tumors refractory to treatment or lacking standard options
- Phase II expansion: specific advanced solid tumors including mCRPC, triple-negative breast cancer (TNBC), and MMR/MSI defective tumors, meeting detailed cohort-specific criteria including prior treatments and tumor markers
You will not qualify if you...
- Radiotherapy (except single palliative doses), chemotherapy, immunotherapy, or endocrine therapy within 4 weeks before treatment; longer washouts for some treatments
- Ongoing significant side effects from prior treatments above grade 1, except alopecia or judged not to exclude
- Symptomatic brain or leptomeningeal metastases; asymptomatic stable brain metastases allowed
- Women of childbearing potential, pregnant or lactating women unless using effective contraception
- Male patients with partners of childbearing potential unless using effective contraception
- Recent major thoracic or abdominal surgery from which recovery is incomplete
- High medical risk due to uncontrolled infection or systemic diseases
- Known active infections with Hepatitis B, Hepatitis C, or HIV
- Prior bone marrow transplant or extensive bone marrow radiotherapy within 8 weeks
- Significant heart disease or abnormal heart test results
- Participation in other interventional clinical trials during this trial
- Prior malignancies except certain treated cancers with no recurrence for 5 years
- Other serious medical conditions affecting compliance or safety
- History of severe immune-related adverse events from prior immunotherapy
- Use of systemic corticosteroids above replacement doses
- Recent live vaccine administration within 30 days
- Known allergies to TT-702 or darolutamide or their ingredients
- Use of drugs that affect CYP3A enzyme activity
- Any other condition considered unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom, SM2 5PT
Actively Recruiting
2
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
3
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
J
Johann de Bono, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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