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Kinase Inhibitor

Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer

Phase 1

Waitlist Available

Led By Sarina A. Piha-Paul, MD

Research Sponsored by TransThera Sciences (Nanjing), Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years to 75 years at the time of provision of informed consent

Dose Escalation Cohorts: Histopathological or cytologically documented locally advanced or metastatic solid tumors who have no available standard therapeutic treatment options Dose Expansion Cohorts: Histopathological or cytologically documented locally advanced or metastatic TNBC or SATs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called TT-00420 for the treatment of triple negative breast cancer and other advanced solid tumors. The trial has two parts - one where they test different doses of the

Who is the study for?

This trial is for adults aged 18-75 with advanced solid tumors or triple negative breast cancer (TNBC) that have no standard treatment options left. Participants must have at least one measurable tumor and be in good physical condition (ECOG status of 0 or 1). They should also meet certain blood cell count criteria and liver function limits.

What is being tested?

The study tests TT-00420, a new oral drug aimed at inhibiting specific enzymes to fight TNBC and other solid tumors. It includes an initial phase to find the right dose followed by a second phase to confirm this dose's safety and effectiveness.

What are the potential side effects?

As TT-00420 is being tested for the first time in humans, potential side effects are not fully known but may include typical reactions related to kinase inhibitors such as fatigue, nausea, diarrhea, rash, and possible effects on blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have advanced cancer with no standard treatment options left.

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My breast cancer is triple-negative and lacks estrogen and progesterone receptors.

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My cancer did not respond or has returned after chemotherapy.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) and/or Dose Limiting Toxicity (DLT)

Secondary study objectives

Disease Control Rate (DCR)

Dose Recommended for Dose Expansion (DRDE)

Duration of Response (DOR)

+9 more

Other study objectives

Exploratory Biomarker Assay

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

A Dose Expansion cohort will be opened to enroll patients with selected advanced solid tumors and evaluate the safety, PK and preliminary efficacy of TT-00420 to determine the recommended phase 2 dose in patients with advanced solid tumors.

Group II: Dose EscalationExperimental Treatment1 Intervention

Eligible adult patients with advanced solid tumors will be enrolled into Dose Escalation cohorts and treated with TT-00420 at different dose cohorts. Starting dose will be 1 mg p.o., q.d. An ABLRM guided by the EWOC principle will evaluate the risk of under-dose or over-dose for the dose tested in each cohort and provide the recommendation dose for next cohort. Dose Escalation Teleconference will be held after the last evaluable patient complete Cycle 1 treatment in each dose cohort to evaluate DLT, determine MTD and/or DRDE.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TT-00420

2021

Completed Phase 2

~260

0 / 5Eligibility criteria met