RecruitingPhase 1/2

TT-702 in Patients With Advanced Solid Tumours.

United Kingdom60 participantsStarted 2022-01-19

Plain-language summary

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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be able to provide informed consent and be capable of co-operating with IMP administration, procedures and follow-up.
. Be willing to provide samples (blood and tissue) as required.
. Consent to access any available archival tissue.
. Consent for fresh tumour biopsy samples at baseline and on trial (may be Investigator mandated for patients in the dose escalation phase. Investigators will consider whether a biopsy is feasible for the patient in the dose escalation phase and this will not impede participation in the trial if biopsy is not a suitable option.
. Life expectancy estimated by the Investigator to be at least 12 weeks.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
. Aged 16 years or over at the time consent is given.
. Haematological and biochemical indices within the protocol specified ranges.

Exclusion criteria

. Radiotherapy (except single fractions for palliative reasons), endocrine therapy during the previous four weeks, immunotherapy and chemotherapy during the previous four weeks(previous six weeks for nitrosoureas, Mitomycin-C) before receiving TT-702. A washout period of eight weeks is required for enzalutamide and apalutamide before the patient receives their first dose of TT-702. A washout period of 4 weeks or 5 half-lives whichever is shorter for any other previous preceding IMPs is required before the patient receives their first dose of TT-702 (no washout is needed from ICI).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Dose Limiting Toxicities (DLTs) (Dose Escalation Phase)

Timeframe: From the first dose in Cycle 0, until completion of Cycle 1 (3 weeks [+ 3-9 days to account for initial pharmacokinetic (PK) profiling period following the Cycle 0 dose]).

Number of Treatment-Emergent AEs (TEAEs), Related TEAEs and Grade 3, 4 or 5 TEAEs (Dose Escalation Phase)

Timeframe: From the time of first dose until the end of the safety follow-up period for TT-702.

Objective Response Rate (ORR)

Timeframe: From the first dose and until the final radiological disease assessment at the off-study visit.

Number and Percentage of Participants that Achieved Clinical Benefit Assessed by PCWG3 and RECIST v1.1 (Expansion Phase)

Timeframe: From the first dose and until the final radiological disease assessment at the off-study visit.

Trial details

NCT IDNCT05272709

SponsorCancer Research UK

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Johann de Bono, Prof

+44 (0)208 722 4029 Johann.debono@icr.ac.uk

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be able to provide informed consent and be capable of co-operating with IMP administration, procedures and follow-up.
. Be willing to provide samples (blood and tissue) as required.
. Consent to access any available archival tissue.
. Consent for fresh tumour biopsy samples at baseline and on trial (may be Investigator mandated for patients in the dose escalation phase. Investigators will consider whether a biopsy is feasible for the patient in the dose escalation phase and this will not impede participation in the trial if biopsy is not a suitable option.
. Life expectancy estimated by the Investigator to be at least 12 weeks.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
. Aged 16 years or over at the time consent is given.
. Haematological and biochemical indices within the protocol specified ranges.

Exclusion criteria

. Radiotherapy (except single fractions for palliative reasons), endocrine therapy during the previous four weeks, immunotherapy and chemotherapy during the previous four weeks(previous six weeks for nitrosoureas, Mitomycin-C) before receiving TT-702. A washout period of eight weeks is required for enzalutamide and apalutamide before the patient receives their first dose of TT-702. A washout period of 4 weeks or 5 half-lives whichever is shorter for any other previous preceding IMPs is required before the patient receives their first dose of TT-702 (no washout is needed from ICI).

What they're measuring

Number of Dose Limiting Toxicities (DLTs) (Dose Escalation Phase)

Timeframe: From the first dose in Cycle 0, until completion of Cycle 1 (3 weeks [+ 3-9 days to account for initial pharmacokinetic (PK) profiling period following the Cycle 0 dose]).

Number of Treatment-Emergent AEs (TEAEs), Related TEAEs and Grade 3, 4 or 5 TEAEs (Dose Escalation Phase)

Timeframe: From the time of first dose until the end of the safety follow-up period for TT-702.

Objective Response Rate (ORR)

Timeframe: From the first dose and until the final radiological disease assessment at the off-study visit.

Number and Percentage of Participants that Achieved Clinical Benefit Assessed by PCWG3 and RECIST v1.1 (Expansion Phase)

Timeframe: From the first dose and until the final radiological disease assessment at the off-study visit.