RecruitingPhase 1

A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors

A Phase 1, Open-label Dose Escalation and Expansion Study Of PT0511 in Participants With KRAS Mutated OR Amplified Advanced 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 the safety of PT0511 and finds doses for future studies. It is for adults with advanced solid cancers that have certain changes in the KRAS gene. PT0511 is tested alone and with cetuximab for people with colorectal cancer (cancer of the colon or rectum).

The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).

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

Eligibility

Who can join

  • Be an adult. The age rule has conflicting wording; ask the study team to confirm.
  • Have a solid cancer confirmed by tissue or cell testing that has grown nearby or spread to other parts of the body.
  • Have an approved lab test showing a KRAS gene change or extra copies of an unchanged KRAS gene.
  • Have had 1 to 4 treatments that work throughout the body, or be unable to tolerate or receive available treatments known to help.
  • Have cancer that can be measured using the study’s rules.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Agree to avoid becoming pregnant or fathering a child from screening until 90 days after the last treatment dose.

Who can't join

  • Active cancer in the brain or its lining. Treated brain cancer may be allowed if it meets strict rules. Another cancer within 2 years may also exclude you, with exceptions for certain cancers.
  • Side effects from past cancer treatment that have not cleared, recent cancer or study treatment, another treatment study, or past use of a KRAS/RAS degrader drug. Some hormone treatments are allowed.
  • Serious heart or blood vessel disease within 6 months, certain abnormal heart tests, or blood tests showing poor blood cell, liver, or kidney function.
  • An infection needing antibiotics within 7 days, HIV that meets certain immune, virus, or medicine-related limits, or active hepatitis B or C. Some treated hepatitis infections are allowed.
  • Certain liver diseases or blocked bile ducts; major surgery within 4 weeks; or surgery problems that prevent study visits or tests.
  • An allergy to a study product, or a health condition that prevents informed consent or following study steps. In the first dose-testing part, certain medicines that affect drug levels are not allowed.
  • A positive pregnancy test near the study start requires review under the study’s pregnancy rules.
  • Breastfeeding, or planning to breastfeed during treatment or within 28 days after the last dose.

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

Official eligibility criteria

Inclusion Criteria: * Men or women less than or equal to (\>=) 18 years of age * Histologically or cytologically confirmed advanced or metastatic solid malignancy * Participant has a pathologically documented, locally advanced or metastatic malignancy with any KRAS mutation or wild-type (WT) KRAS amplification identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test * Participant must have received at least 1 and no more than 4 prior systemic therapies or be intolerant or ineligible for available therapies known to provide clinical benefit * Measurable disease (RECIST 1.1 Criteria) * ECOG Performance Status 0 or 1 * Willingness to avoid pregnancy or fathering children screening through 90 days after the last dose of study treatment Exclusion Criteria: Cancer History * Active brain metastasis or carcinomatous meningitis. If participants have had brain metastases resected or have received radiation therapy, they may be eligible if: (1) study treatment begins at least 4 weeks from the end of brain-specific therapy, (2) residual neurological symptoms Grade \<=2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain MRI documents no new/worsening brain lesions * History of any other malignancy within the past 2 years, except: * Malignancy treated with curative intent and with no known active disease present \>=2 years before enrolment and felt to be at low risk for recurrence by the investigator * Basal or squamous cell carcinoma of the skin, in situ cervical cancer, early -stage endometrial cancer that has been definitively treated, superficial bladder cancer, Gleason 6/7 treated prostate cancer, and ductal carcinoma in situ or lobular carcinoma in situ of the breast Prior Cancer Therapy * Unresolved toxicities from prior anti-cancer therapies. Participants with prior endocrine replacement therapies are eligible for entry even if administered to treat endocrine deficiency due to the prior anti-cancer therapy * Concurrent participation in another interventional clinical study. * Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of study drug: * At least 14 days for chemotherapy or targeted small-molecule therapy * At least 28 days for a prior monoclonal antibody * At least 28 days or 5 half-lives (whichever is longer) for all other investigational study drugs or devices. For drugs with very long half-lives, participants may be allowed to enroll prior to 5 half-lives at the discretion of the investigator in discussion with the medical monitor * Note: Concurrent hormonal therapy for prostate or breast cancer is allowable * Prior treatment with a KRAS/RAS degrader Medical History * Significant cardiovascular disease within 6 months of starting study therapy * Active infection requiring antibiotics within 7 days of study treatment. * Known HIV infection with a CD4+ T-cell count \<200 cells/mcL and/or a detectable viral load per parameters of assay and/or on an anti-retroviral regimen containing a strong or moderate CYP3A4/5 inhibitor or inducer and/or on a new anti-retroviral regimen for less than 28 days prior to the initiation of study treatment * Known history of drug-induced liver injury; primary biliary cirrhosis; or ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension * Major surgery within 4 weeks of the start of study therapy or postoperative complications preventing the participant from adhering to protocol assessments and procedures * Known hypersensitivity to any of the products to be administered during dosing * Any disease or disorder that, in the opinion of the investigator, may compromise the ability of the participant to provide written informed consent and/or to comply with all required study procedures Medications • Part 1a (Dose escalation): Use of a strong or moderate CYP3A4/5 inhibitor or inducer, Use of a strong P-gp inhibitor or inducer Organ Function • Participants with laboratory values indicating inadequate hematology, hepatic, or renal function Diagnostic Assessments * Clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG * Baseline QT interval corrected for heart rate using Fridericia's formula (QTcF) \>=470 msec * Female participants of childbearing age with a positive urine or serum test within 7 days of study start or confirmation from Ob/Gyn that any positive bHCG test is not representative of an ongoing pregnancy * Women who are lactating/breast feeding or who plan to breastfeed while on study through 28 days after receiving the last dose of study drug * Active HBV infection. Participants with resolved infection or who are on Stable antiviral therapy are eligible * Active HCV infection. Participants who have completed definitive antiviral therapy with post treatment confirmation of eradication are eligible

Study sites (5)

MA

TX

UT

VA