Advanced Solid TumorPhase 1/2NCT07300943
Study in Advanced Solid Tumor Patients
A Phase 1/2 study testing CLIO-8221 in people with Advanced Solid Tumor, run by Callio Therapeutics at 11 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CLIO-8221
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 19 Mar 2026to 17 Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
Australia6 sites, 6 recruiting
- Recruiting
Peter Maccallum Cancer Centre
Box Hill, Victoria, 3128
Stephen Luen, Dr, 0385595000, stephen.luen@petermac.org
- Recruiting
AlfredHealth
Heidelberg, Victoria, 3084
Malaka Ameratunga, Dr, 0390763129, malaka.ameratunga@austin.org.au
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3052
Stephen Luen, Dr, 0385595000, Stephen.Luen@petermac.org
- Recruiting
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
Peter Lau, Dr, 0863825100, actcstartup@linear.org.au
- Recruiting
Scientia Clinical Research
Randwick, New South Wales, 2031
Charlotte Lemech, Dr, 0293825800, charlotte.lemech@scientiaclinicalresearch.com.au
- Recruiting
Integrated Clinical Oncology Network Pty Ltd
South Brisbane, Queensland, 4101
Jermaine Coward, Dr, 0737374500, drjcoward@iconcancercare.com.au
United States5 sites, 5 recruiting
- Not yet recruiting
DFCI
Boston, Massachusetts, 02215-5450
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Desirae Dufner, Dr, 713-745-7813, ddufner@mdanderson.org
- Recruiting
Sarah Cannon Research Institute 335 24th Avenue North, Suite 400
Nashville, Tennessee, 37203
SCRI Patient Intake Team
615-329-7640, SCRINewPatient@USONCOLOGY.com
- Recruiting
START San Antonio
San Antonio, Texas, 78229
- Recruiting
START Mountain
West Valley City, Utah, 84119
About this study
Official title: A Phase 1/2 Study of CLIO-8221 in Patients With Advanced Solid Tumors
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.
Read the detailed 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- CLIO-8221
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLIO-8221Drug
intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CLIO-8221 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence, severity, and seriousness of adverse events (AEs)
Type, incidence, severity, and seriousness of AEs occurred
Measured: Through end of treatment, up to approximately 2 years.
Type, incidence, and severity of laboratory abnormalities
Type, incidence, and severity of laboratory abnormalities occurred
Measured: 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
Measured: From first dose through study day 21.
Secondary outcomes (10)
Objective Response Rate
Participants who achieve partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Measured: Through disease progression, up to approximately 2 years.
Disease control rate
Participants who achieve stable disease, partial or complete response per RECIST v1.1 criteria
Measured: Through disease progression, up to approximately 2 years.
Progression-free survival
Time from first dose of CLIO-8221 to disease progression or death, whichever occurs first
Measured: Up to approximately 2 years.
Duration of objective response
Time from the first documented objective tumor response (complete or partial), subsequently confirmed, to radiographic progression or death
Measured: 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
Measure of CLIO-8221 AUC in plasma
Measured: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Maximum Concentration (Cmax) for CLIO-8221
Measure of CLIO-8221 Cmax in plasma
Measured: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for CLIO-8221
Measure of CLIO-8221 Tmax in plasma
Measured: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Total Clearance (CL) for CLIO-8221
Measure of CLIO-8221 CL in plasma
Measured: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Volume of distribution at steady state (Vd) for CLIO-8221
Measure of CLIO-8221 Vd in plasma
Measured: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Apparent Terminal Half-life (t1/2) for CLIO-8221
Measure of CLIO-8221 t1/2 in plasma
Measured: Varying timepoints through end of treatment, up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start19 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion17 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Callio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300943
- Sponsor's protocol ID
- CLIO-8221-001
- Status last verified
- Apr 2026
- First submitted
- 14 Dec 2025
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of CLIO-8221 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07300943
- Acronym / sponsor ID
- CLIO-8221-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Callio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 17 Jul 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and dose level expansion | Experimental | Drug: CLIO-8221Phase 1: CLIO-8221 monotherapy in escalating doses. Phase 2: Phase 2 will be initiated in tumor-specific expansion cohorts at selected doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLIO-8221intravenous (IV) infusion | Drug | Dose escalation and dose level expansion |
Primary outcome
Type, incidence, severity, and seriousness of adverse events (AEs)
Time frame: Through end of treatment, up to approximately 2 years.
Type, incidence, severity, and seriousness of AEs occurred
Type, incidence, and severity of laboratory abnormalities
Time frame: Through end of treatment, up to approximately 2 years.
Type, incidence, and severity of laboratory abnormalities occurred
Incidence of dose limiting toxicities dose (RP2D) of CLIO-8221
Time frame: From first dose through study day 21.
Incidence of dose limiting toxicities occurred
10 secondary outcomes
Objective Response Rate
Time frame: Through disease progression, up to approximately 2 years.
Disease control rate
Time frame: Through disease progression, up to approximately 2 years.
Progression-free survival
Time frame: Up to approximately 2 years.
Duration of objective response
Time frame: 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
Time frame: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Maximum Concentration (Cmax) for CLIO-8221
Time frame: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for CLIO-8221
Time frame: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Total Clearance (CL) for CLIO-8221
Time frame: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Volume of distribution at steady state (Vd) for CLIO-8221
Time frame: Varying timepoints through end of treatment, up to approximately 2 years.
Pharmacokinetic Parameter Apparent Terminal Half-life (t1/2) for CLIO-8221
Time frame: Varying timepoints through end of treatment, up to approximately 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CLIO-8221 in people with Advanced Solid Tumor, run by Callio Therapeutics at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CMO (206-602-3134, clinical@calliotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, incidence, severity, and seriousness of adverse events (AEs) (time frame: Through end of treatment, up to approximately 2 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.