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A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors

ConditionsAdvanced or Metastatic Solid TumorsTriple Negative Breast Cancer (TNBC)HR+ Breast CancerColon CancerGastric CancerHepatecellular CarcinomaNSCLC (Advanced Non-small Cell Lung Cancer)MesotheliomaPancreatic Carcinoma MetastaticHormone Refractory Prostate CancerSoft Tissue Sarcomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSHY Therapeutics

About this trial

This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SHY-ONC6 in participants with advanced or metastatic solid tumors who have progressed on or are intolerant to standard therapies. The study will consist of 2 parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥18 years of age.

Life expectancy >3 months.

ECOG performance status 0-1.

Histologically/cytologically confirmed advanced or metastatic solid tumors that have progressed on or are intolerant/unsuitable for standard therapies. Eligible tumor types: TNBC, HR+ breast cancer, colon cancer, gastric cancer, HCC, NSCLC (adeno and squamous), mesothelioma, pancreatic cancer, HRPC, soft tissue sarcoma; other tumor types after Medical Monitor discussion. Stable CNS metastases ≥4 weeks post-radiotherapy and off steroids ≥14 days are permitted.

Disqualifiers

High-risk cardiovascular disease.

Concurrent anti-cancer treatment.

Active infection requiring systemic treatment within 2 weeks pre-dose.

History of another malignancy (with standard exceptions for in situ disease, non-melanoma skin cancers, and remission ≥2 years).

Trial design

Design model

Single group

Treatments tested in this trial

  • SHY-ONC6

    Drug

    Participants receive SHY-ONC6 administered orally once daily in 21-day cycles. SHY-ONC6 will be administered until the participant withdraws from study, experiences unacceptable toxicity or other safety event, or their disease progresses.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SHY-ONC6Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs)

Adverse events and serious adverse events graded per NCI CTCAE v6.0; supported by laboratory tests, vital signs, physical examinations, and triplicate 12-lead ECG. Dose-limiting toxicities assessed during Cycle 1 (Days 1 through 21).

Time frame
Dose-limiting toxicities assessed from first dose through Day 21 of Cycle 1 (each cycle is 21 days). Adverse events and serious adverse events collected from first dose through 30 days after last dose.
2

Maximum Tolerated Dose (MTD)

MTD determined using the BOIN (Bayesian Optimal Interval) design, with a target dose-limiting toxicity rate of 0.30, based on dose-limiting toxicity incidence observed during Cycle 1.

Time frame
Determined at the end of the Cycle 1 dose-limiting toxicity evaluation period (Cycle 1 is 21 days).
3

Recommended Phase 2 Dose (RP2D)

Phase 1a: RP2D range determined from dose-limiting toxicity, adverse event, and serious adverse event incidence together with the MTD determination. Phase 1b: RP2D defined by integrated safety, efficacy, pharmacodynamic, and pharmacokinetic data.

Time frame
Phase 1a: at the end of Cycle 1 (each cycle is 21 days). Phase 1b: through end of treatment plus a 30-day safety follow-up period.

Secondary outcomes

1

Maximum Plasma Concentration (Cmax)

Maximum observed plasma concentration of study drug.

Time frame
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
2

Area Under the Plasma Concentration-Time Curve (AUC)

Area under the plasma concentration-versus-time curve for study drug.

Time frame
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
3

Time to Maximum Plasma Concentration (Tmax)

Time from dosing to observed maximum plasma concentration of study drug.

Time frame
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
4

Terminal Elimination Half-Life (t1/2)

Terminal elimination half-life of study drug.

Time frame
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).

Other outcomes

Sponsors and contacts

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

SHY Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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