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RecruitingPhase 1

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests OP-3136 in people for the first time, alone or with other cancer drugs. It checks safety, how the drug works in the body, and whether it may help treat cancer. It is for people with certain breast, prostate, or lung cancers that are advanced or have spread.

This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors. This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have advanced cancer or cancer that has spread: ER-positive, HER2-negative breast cancer; prostate cancer that keeps growing despite treatment to lower testosterone; or non-small cell lung cancer. Lung cancer is included only in Part 1.
  • For Part 1A, which tests OP-3136 alone: the cancer cannot be removed by surgery or has spread. No treatment that could extend life is available, or available treatments cause side effects you cannot tolerate or no longer work.
  • For Parts 1B and 1C, which add fulvestrant or palazestrant: breast cancer must have worsened during or after hormone treatment with a CDK4/6 inhibitor, a drug that blocks cancer growth. For advanced cancer, you must have had no more than 2 courses of hormone treatment and no more than 1 course of chemotherapy or an antibody-drug conjugate, a drug that delivers cancer-killing medicine to cancer cells.
  • For Part 2A breast cancer treatment with OP-3136 alone: you must have had up to 3 courses of hormone treatment, including one with a CDK4/6 inhibitor, and up to 1 course of chemotherapy or an antibody-drug conjugate.
  • For Part 2A prostate cancer treatment with OP-3136 alone: you must have had up to 4 courses of medicine that treats cancer throughout the body. These must include a drug that blocks male hormone signals.
  • For Part 2B, which adds fulvestrant or palazestrant: breast cancer must have worsened during or after hormone treatment with a CDK4/6 inhibitor. For advanced cancer, you must have had no more than 2 courses of hormone treatment and no more than 1 course of chemotherapy or an antibody-drug conjugate.
  • Other rules for joining may apply.

Who can't join

  • Past treatment with a KAT6A/B inhibitor, the same type of drug as OP-3136.
  • Cancer that has spread to internal organs, causes symptoms, and could soon cause life-threatening problems.
  • Cancer in the brain, spinal cord, or their coverings, or pressure on the spinal cord, that needs treatment aimed at these areas. You may also be excluded if symptoms and scans have not been stable for 2 months before the first dose, or if you need or take steroids for cancer in these areas.
  • Disease affecting blood flow in the brain, including a mini-stroke, within 6 months before the first dose.
  • Poor heart function or serious heart disease within 6 months before the first dose.
  • Other rules that prevent joining may apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2). * Part 1A (Dose escalation for OP-3136 monotherapy): Participants must have a tumor that is unresectable or metastatic and for which life prolonging measures do not exist or available therapies are intolerable or no longer effective. * Part 1B (Dose escalation for OP-3136 in combination with fulvestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting. * Part 1C (Dose escalation for OP-3136 in combination with palazestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting. * Part 2A (Dose Expansion in ER+ HER2- mBC for OP-3136 monotherapy): Participants must have received up to 3 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and up to 1 prior line of chemotherapy or an antibody-drug conjugate. * Part 2A (Dose Expansion in mCRPC for OP-3136 monotherapy): Participants must have received up to 4 lines of prior systemic therapy for prostate cancer. Prior therapy must include treatment with an androgen receptor pathway inhibitor(s). * Part 2B (Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with fulvestrant OR Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with palazestrant): Participants must have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting. Participants must have received no more than 2 prior lines of endocrine therapy in the advanced or metastatic setting and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting. Key Exclusion Criteria: * Prior therapy with KAT6A/B inhibitor in any treatment setting. * Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term. * Known active or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require CNS-specific treatment, or participants who did not demonstrate clinical and radiologic stability during the last 2 months prior to the first dose of study treatment or require or are currently on steroid therapy for CNS metastases. * History of cerebral vascular disease, including transient ischemic attack, within 6 months prior to the first dose of study treatment. * History of or ongoing impaired cardiac function or clinically significant cardiac disease within 6 months prior to the first dose of study treatment. Note: Additional inclusion/exclusion criteria may apply.

Study sites (13)

AZ

CO

FL

LA

MA

MI

NY

OH

TN

TX

UT