Health TrialsbyHealthPanel

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

ConditionsBreast CancerEndometrial CancerOvarian CancerLung Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaSolid TumorCervical Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTerremoto Biosciences Inc.

About this trial

This is a Phase 1/2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT/PI3K/PTEN pathway alterations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Metastatic or locally advanced, unresectable disease

No available treatment with curative intent

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Adequate organ function

Disqualifiers

Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration

Clinically significant abnormalities of glucose metabolism

Active brain metastases or carcinomatous meningitis.

History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug

Trial design

Design model

Parallel

Treatments tested in this trial

  • TER-2013

    Drug

    Oral Capsules

  • Fulvestrant injection

    Drug

    Fulvestrant 500 mg Intramuscular Injection

Treatment groups

205 Participants
are divided into 4 treatment groups
Group A: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Combination Therapy Dose EscalationExperimental treatment 2 interventions
Group C: Monotherapy Dose ExpansionExperimental treatment 1 intervention
Group D: Combination Therapy Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Patients who Experience Dose-Limiting Toxicity

Time frame
28 Days
2

Number of patients who experience a treatment-related adverse event

Time frame
Up to 2 years
3

Objective Response Rate as assessed by RECIST v1.1

Time frame
Up to 2 years
4

Duration of Response as assessed by RECIST v1.1

Time frame
Up to 2 years

Secondary outcomes

1

Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013

Time frame
Up to 2 years
2

Maximum concentration (Cmax) of TER-2013

Time frame
Up to 2 years
3

Time to maximum concentration (Tmax) of TER-2013

Time frame
Up to 2 years
4

Terminal elimination half-life (T1/2) of TER-2013

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Terremoto Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now