Study in Advanced Solid Tumor Patients

Sponsor: Callio Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT07300943

The trial involves Phase 1 dose-escalation to determine MTD/RDE and Phase 2 tumor-specific expansions for CLIO-8221, an IV drug. Eligible patients have advanced solid tumors, metastatic/unresectable disease, LVEF ≥50%, ECOG 0-1, and measurable disease per RECIST 1.1. Safety, PK/PD, and efficacy data will guide dosing and further development.

Patient Parameters

Program Overview

The study will be conducted in 2 phases: Phase 1: Dose-escalation and Dose Level Expansion, Phase 1 will determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). Phase 2: Tumor-Specific Expansions with Dose Optimization, Phase 2 will further evaluate CLIO-8221 in tumor-specific expansion cohorts to optimize dosing and assess preliminary efficacy.

Description

Phase 1: Dose-escalation and Dose Level Expansion. Dose escalation safety data will be reviewed by a Safety Monitoring Committee (SMC) to guide dosing decisions. Backfill enrollment may be used to further characterize safety, PK/PD, and antitumor activity.

Phase 2: Tumor-Specific Expansions with Dose Optimization. Phase 2 will further evaluate CLIO-8221 in tumor-specific expansion cohorts to optimize dosing and assess preliminary efficacy. Safety, tolerability, PK/PD, and response data will support selection of the recommended Phase 2 dose (RP2D) for further development.

Eligibility Criteria

Inclusion Criteria

  • Patients with advanced solid tumors
  • Patients must have metastatic or unresectable disease not suitable for further local treatment and should have received prior beneficial therapies unless ineligible, unwilling, or lacking access.
  • LVEF ≥50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Measurable disease per RECIST version 1.1 at baseline

Exclusion Criteria

  • Prior anti-tumor treatment with an ATRi.
  • Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, and Stage I uterine cancer.
  • History of uncontrolled seizure disorders or clinically significant neurodegenerative disorders, including progressive peripheral neuropathy. Stable Grade ≤ 2 peripheral neuropathy is allowed.
  • Clinically significant autoimmune disease, either currently present or present within the previous 2 years, including a current requirement for systemic immunosuppressive therapy equivalent to >10 mg/prednisone daily (local immunosuppressive therapy such as inhaled or topical corticosteroids is allowed).
  • Any uncontrolled Grade ≥ 3 (per NCI CTCAE version 6.0) viral, bacterial, or fungal infection within 2 weeks prior to Cycle 1 Day 1. Routine antimicrobial prophylaxis is permitted.
  • History of hepatic cirrhosis, autoimmune hepatitis, or drug-associated hepatitis within the past 12 months.
  • Uncontrolled diabetes mellitus, defined as Hgb A1c ≥8% or Hgb A1c between 7% and <8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
  • Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.

Additional protocol defined inclusion/exclusion criteria may apply

Locations

FACILITYZIPCITYSTATE
DFCI02215-5450BostonMassachusetts
Sarah Cannon Research Institute 335 24th Avenue North, Suite 40037203NashvilleTennessee
MD Anderson Cancer Center77030HoustonTexas
START San Antonio78229San AntonioTexas
START Mountain84119West Valley CityUtah

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