Study in Advanced Solid Tumor Patients

NCT07300943 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CLIO-8221-001
• Study Type: interventional
• Target: 306
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Type, incidence, severity, and seriousness of adverse events (AEs)

  Type, incidence, severity, and seriousness of AEs occurred

  Through end of treatment, up to approximately 2 years.

• Type, incidence, and severity of laboratory abnormalities

  Type, incidence, and severity of laboratory abnormalities occurred

  Through end of treatment, up to approximately 2 years.

• Incidence of dose limiting toxicities dose (RP2D) of CLIO-8221

  Incidence of dose limiting toxicities occurred

  From first dose through study day 21.

Secondary Outcomes (10)

• Objective Response Rate

  Through disease progression, up to approximately 2 years.

• Disease control rate

  Through disease progression, up to approximately 2 years.

• Progression-free survival

  Up to approximately 2 years.

• Duration of objective response

  From the date of enrollment until a confirmed partial or complete response is achieved, assessed up to 2 years.

• Pharmacokinetic Parameter Area Under the Curve (AUC) for CLIO-8221

  Varying timepoints through end of treatment, up to approximately 2 years.

Study Arms (1)

Dose escalation and dose level expansion

EXPERIMENTAL

Phase 1: CLIO-8221 monotherapy in escalating doses. Phase 2: Phase 2 will be initiated in tumor-specific expansion cohorts at selected doses.

Drug: CLIO-8221

Interventions

CLIO-8221 DRUG

intravenous (IV) infusion

Dose escalation and dose level expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Callio Therapeutics: lead

Study Sites (11)

DFCI

Boston, Massachusetts, 02215-5450, United States

NOT YET RECRUITING

Sarah Cannon Research Institute 335 24th Avenue North, Suite 400

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

START Mountain

West Valley City, Utah, 84119, United States

RECRUITING

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

RECRUITING

Integrated Clinical Oncology Network Pty Ltd

South Brisbane, Queensland, 4101, Australia

RECRUITING

Peter Maccallum Cancer Centre

Box Hill, Victoria, 3128, Australia

RECRUITING

AlfredHealth

Heidelberg, Victoria, 3084, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, 3052, Australia

RECRUITING

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

RECRUITING

Central Study Contacts

CMO

CONTACT

206-602-3134; clinical@calliotx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No, this is an open-label trial
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1: no randomization will be performed. Phase 2: participants in each cohort will be randomized with a 1:1 ratio to receive one of the expansion doses of CLIO-8221.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 24, 2025
• Study Start: March 19, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 17, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); US (5)