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A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors

ConditionsOncologyMEK MutationRAF Gene MutationRas (KRAS or NRAS) Gene MutationMelanomaNSCLCGliomaSolid Tumor, AdultMAPK Pathway Gene Mutation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNested Therapeutics, Inc

About this trial

This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must be ≥18 years old (or of legal age of consent in the country in which the study is taking place) at the time of signing the informed consent.

Subjects who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy does not exist, no longer provides benefit, or is not tolerated by the subject, or the subject has been assessed by the Investigator as not being suitable for SoC therapy.

Part A: Subjects with any solid tumor with genetic alteration of or evidence of tumor dependence upon the RAS/MAPK pathway (subject to additional restrictions specified in the study protocol)

Activating NRAS mutations

Disqualifiers

Conditions interfering with oral intake of NST-628

Conditions interfering with intestinal absorption of an orally administered drug

A history or current evidence of significant retinal pathology leading to increased risk of RVO

A history or evidence of cardiovascular risk

Trial design

Design model

Sequential

Treatments tested in this trial

  • NST-628

    Drug

    NST-628 is a small molecule non-covalent pan-RAF/MEK dual molecular glue targeting RAF and MEK nodes of MAPK pathway.

Treatment groups

230 Participants
are divided into 1 treatment group
Group A: Part A Dose Escalation and Part B Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors

Adverse effects

Time frame
Through study completion, an average of 1 year
2

Part A: Determine the recommended dose for expansion of NST-628

Dose limiting toxicities (DLTs)

Time frame
The first 28 days of treatment (DLTs)
3

Part B: Evaluate objective tumor response rate

Objective response per RECIST v. 1.1 or other response assessment tool standard for a given tumor type.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Part A: Evaluate objective tumor response rate

Objective response per RECIST v. 1.1 or other response assessment tool standard for a given tumor type.

Time frame
Through study completion, an average of 1 year
2

Part A and B: Evaluate progression free survival (PFS)

PFS defined as the time to first occurrence of disease progression per RECIST v1.1 (or other response assessment tool standard for a given tumor type) or death

Time frame
Through study completion, an average of 1 year
3

Part A and B: Evaluate overall survival (OS)

Overall survival (OS) defined as the time to death

Time frame
Through study completion, an average of 2 years
4

Part A and B: Characterize the pharmacokinetics of NST-628

NST-628 concentrations in plasma

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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

Nested Therapeutics, Inc

Lead sponsor

Source ClinicalTrials.gov
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