A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-11

Study Completion Date

2026-03-31

Brief Summary

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This is a first-in-human, dose escalation, repeat-dose, multi-center, open-label study evaluating safety, tolerability, PK, and preliminary antitumor activity of PEEL-224 in patients with advanced solid tumors.

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Detailed Description

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This is a first-in-human, dose escalation, repeat-dose, multi-center, open-label study evaluating safety, tolerability, PK, and preliminary antitumor activity of a novel topoisomerase I inhibitor (PEEL-224) in patients with advanced solid tumors. Dose escalation will be guided by the modified toxicity probability interval-2 (mTPI-2) design with a target toxicity rate of 25% and an acceptable DLT interval of 20% to 30%. Cohorts of 2 or more patients will be sequentially enrolled at progressively higher dose levels of PEEL-224. For each dose level, all patients must complete Cycle 1 before the decision to dose escalate the next cohort of patients is made.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A: PEEL-224 Dose Escalation

PEEL-224 is administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. The study will begin at a low starting dose and will increase between cohorts according to mTPI-2 until a recommended phase 2 dose is determined. Approximately 10 dose levels are anticipated to be studied.

Group Type EXPERIMENTAL

PEEL-224

Intervention Type DRUG

Lyophilized powder reconstituted with D5W

Part 1B: PEEL-224 Dose Confirmation

PEEL-224 is administered intravenously (IV) on Days 1 and 15 of a 28-day cycle at the dose determined in Part 1A

Group Type EXPERIMENTAL

PEEL-224

Intervention Type DRUG

Lyophilized powder reconstituted with D5W

Part 2: PEEL-224 plus FOLF+B

PEEL-224 is administered intravenously (IV) and in combination with FOLFPB on Days 1 and 15 of a 28-day cycle. Up to 3 dose levels of PEEL-224 will be tested as determined by the results of Part 1.

Group Type EXPERIMENTAL

PEEL-224

Intervention Type DRUG

Lyophilized powder reconstituted with D5W

FOLF+B

Intervention Type DRUG

infusional 5-FU, LV, and bevacizumab

Interventions

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PEEL-224

Lyophilized powder reconstituted with D5W

Intervention Type DRUG

FOLF+B

infusional 5-FU, LV, and bevacizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of colorectal cancer confirmed by local pathology review (histology or cytology) - Part 2 only
* ECOG of 0 or 1
* Have a diagnosis of advanced or metastatic solid tumor that has progressed after prior standard therapy, have been intolerant or ineligible for standard therapy, or have a malignancy for which there is no approved therapy considered standard of care
* Have at least 1 documented measurable lesion as detected by radiological methods at study entry as per Response Evaluation Criteria in Solid Tumors v1.1
* Have adequate bone marrow reserve
* Have adequate liver function
* Have adequate renal function
* Have completed prior anticancer therapy, including investigational agents, ≥28 days or 5 half lives, whichever is shorter, prior to study treatment
* Have resolution of any clinically significant toxic effects of prior therapy

Exclusion Criteria

* Have primary central nervous system tumors
* Have brain or spinal metastases, except if treated by surgery, surgery plus focal radiotherapy, or radiotherapy alone, with no evidence of progression or hemorrhage ≤14 days prior to the first dose of PEEL-224. Have craniospinal radiotherapy ≤12 weeks prior to the first dose of PEEL-224
* Have significant abnormalities in the level of serum electrolytes
* Have received neutrophil growth factor support ≤14 days prior to the first dose of PEEL 224
* Have an active infection ≤14 days prior to the first dose of PEEL-224
* Use of strong cytochrome P450 (CYP)1A2 and CYP3A4 inhibitors and/or inducers ≤14 days prior to the first dose of PEEL-224 or during the study
* Use of systemic corticosteroids ≤14 days prior to the first dose of PEEL-224
* Are known to be HIV-positive, unless CD4 + lymphocyte count ≥ 300/μL, undetectable viral load; AND Receiving anti-retroviral therapy.
* Have uncontrolled hepatitis B infection or hepatitis C infection;
* Are pregnant or lactating, plan to become pregnant, or plan to donate gametes (ova or sperm) for in vitro fertilization during the study period or for 90 days after the patient's last study-related visit (for eligible patients only, if applicable). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy does not occur during the study will be excluded;
* Have evidence of another malignancy ≤2 years prior to screening (except in situ non melanoma skin cell cancers and in situ cervical carcinoma);
* Are currently enrolled in another therapeutic clinical study or a non-therapeutic clinical study that will conflict with scheduled visits required by this study;
* Have clinically significant, uncontrolled cardiovascular disease
* Have history of cerebrovascular accident, transient ischemic attack, or thrombosis requiring treatment ≤3 months prior to the first dose of PEEL-224
* Have received or will receive a live vaccine ≤14 days prior to the first dose of PEEL 224.
* Have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection ≤14 days of the Screening Visit.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No