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Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

ConditionsClear Cell Renal Cell CarcinomaRenal Cell CarcinomaRCCClear Cell Renal Cell Carcinoma MetastaticccRCCVHL-Associated Clear Cell Renal Cell CarcinomaVHL-Associated Renal Cell CarcinomaKidney Cancer MetastaticKidney Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeomorph, Inc

About this trial

The NEO-811-101 study is an open-label, first-in-human, Phase 1/2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).

Subjects must have progressed on or refused standard therapies.

Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.

Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks.

Disqualifiers

Non-clear cell predominant RCC histologic subtypes.

Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.

Prior or concurrent malignancies with exceptions per protocol.

History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.

Trial design

Design model

Sequential

Treatments tested in this trial

  • NEO-811

    Drug

    NEO-811

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single agent NEO-811 dose escalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent.

TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.

Time frame
Start of Cycle 1 until at least 30 days following the last dose of the last treatment cycle (each treatment cycle is 21 days).
2

Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NEO-811 as a single agent.

The MTD and/or RP2D of NEO-811 as a single agent will be determined.

Time frame
Start of Cycle 1 until at least 30 days following the last dose of the last treatment cycle (each treatment cycle is 21 days).

Secondary outcomes

1

Maximum observed plasma concentration (Cmax) of NEO-811.

Maximum observed plasma concentration (Cmax) of NEO-811 will be determined.

Time frame
Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).
2

Trough observed plasma concentration (Ctrough) of NEO-811.

Trough observed plasma concentration (Ctrough) of NEO-811 will be determined.

Time frame
Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).
3

Time to Cmax (Tmax) of NEO-811.

Time to Cmax (Tmax) of NEO-811 will be determined.

Time frame
Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).
4

Area under the concentration time curve (AUC) of NEO-811.

Area under the concentration time curve (AUC) of NEO-811 will be determined.

Time frame
Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).

Other outcomes

Sponsors and contacts

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

Neomorph, Inc

Lead sponsor

Source ClinicalTrials.gov
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