Advanced Solid TumorsPhase 1SUMMIT-1NCT06779851
A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors
A Phase 1 study testing BPT567 in people with Advanced Solid Tumors, run by Bright Peak Therapeutics Inc at 7 sites in United States.
Trial summary
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) or maximum adminstered dose (MAD) of BPT567 in patients with advanced solid tumors, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BPT567
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Oct 2024to 11 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female aged ≥18 years at the time of signing informed consent form
- Measurable disease per RECIST 1.1
- Histologically- or cytologically-diagnosed, locally advanced unresectable or metastatic solid tumor. Progressed or recurred after previously having received approved standard of care agents that are approved and available in their local geography.
- ECOG Performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ and marrow function
- Contraception during study participation, as applicable
Who cannot join
- Has received systemic small molecule therapy or radiation therapy within 28 days prior to the first dose.
- Treatment with biologic agents including anti-PD-1 or PD-L1 antibodies for less than 6 weeks or 5 half-lives, whichever is shorter, prior to first dose.
- Received any investigational agent less than 28 days or 5 half-lives, whichever is shorter, prior to the first dose.
- Treatment with another IL-18 therapy.
- Received systemic immunosuppressive agents greater than the equivalent of prednisone 10mg daily within 14 days of the study, though inhaled, intranasal, topical or intra-articular corticosteroids are allowed.
- Certain clinically significant intercurrent disease.
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- Primary immune deficiency.
- Active untreated brain or spine metastasis or leptomeningeal metastases.
- Known HIV seroposivitiy, although patients treated for HIV with no detectable viral load for at least 1 month while on a stable regimen of agents are permitted.
- Active hepatitis A or acute or chroming hepatitis B or C infection.
- Received a live virus vaccine within 30 days of enrollment or a COVD vaccine within 14 days.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Start Midwest
Grand Rapids, Michigan, 49546
Hackensack Meridian John Theurer Cancer Center
Hackensack, New Jersey, 07601
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Providence Cancer Institute
Portland, Oregon, 97213
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
Honor Health Research Institute
Scottsdale, Arizona, 85260
About this study
Official title: A Phase 1 Investigation of the Safety, Tolerability and Preliminary Antitumor Activity of BPT567, a Multifunctional PD1-IL18 Immunocytokine in Patients With Advanced Solid Tumors
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) or maximum adminstered dose (MAD) of BPT567 in patients with advanced solid tumors, and establish the recommended dose for expansion cohorts.
- Conditions
- Advanced Solid Tumors
- Being tested
- BPT567
- Keywords
- Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPT567Drug
Immunocytokine infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Study drug BPT567 at multiple dose levels to define MTD or MAD Receives: Drug: BPT567 |
| Phase 1b Dose Expansion | Experimental | Study drug BPT567 at recommended dose for expansion (RDE) cohorts Receives: Drug: BPT567 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT), Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
The MTD will be the highest tested dose of BPT567 at which protocol specified number of patients experience DLT or the MAD, highest administered dose in the absence of DLTs
Measured: Duration of first cycle (28 Days) for each cohort evaluated
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Rate of subjects reporting adverse events or serious adverse events including abnormalities in safety laboratory results
Measured: Through end of study (up to 2 years)
Secondary outcomes (10)
Pharmacokinetic parameter - Maximum Concentration (Cmax)
Maximum concentration of BPT567
Measured: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Time to Maximumn Concentration (Tmax)
Time to maximum concentration of BPT567
Measured: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Terminal Elimination Half-life (T1/2)
Terminal elimination half-life of BPT567
Measured: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Area under the plasma concentration curve up to the last quantifiable time-point ((AUC)0-last))
(AUC)0-last of BPT567
Measured: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Area area under the curve from 0 to infinite time (AUC0-inf)
AUC0-inf of BPT567
Measured: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Anti-drug Antibody (ADA) Response to BPT567
Number of Participants With Anti-drug Antibody (ADA) Response to BPT567
Measured: Predose and postdose at multiple timepoints up to end of treatment (up to 2 years)
Objective response rate (ORR)
Per RECIST V1.1
Measured: Through study completion up to 2 years
Duration of response (DoR)
Per RECIST V1.1
Measured: Through study completion up to 2 years
Disease Control Rate (DCR)
Per RECIST V1.1
Measured: Through study completion up to 2 years
Progression Free Survival (PFS)
Per RECIST V1.1
Measured: Through study completion up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start15 Oct 2024
- Primary completion21 Jan 2026
- Study completion11 Mar 2026
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Ph1a Dose Escalation followed by and Ph 1b Dose Expansion study including multiple expansion cohorts
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Peak Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779851
- Sponsor's protocol ID
- BPT567-101
- Acronym
- SUMMIT-1
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Investigation of the Safety, Tolerability and Preliminary Antitumor Activity of BPT567, a Multifunctional PD1-IL18 Immunocytokine in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06779851
- Acronym / sponsor ID
- SUMMIT-1 / BPT567-101
- Conditions
- Advanced Solid Tumors
- Keywords
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bright Peak Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 17 Jan 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.
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) or maximum adminstered dose (MAD) of BPT567 in patients with advanced solid tumors, and establish the recommended dose for expansion cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Ph1a Dose Escalation followed by and Ph 1b Dose Expansion study including multiple expansion cohorts
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: BPT567Study drug BPT567 at multiple dose levels to define MTD or MAD |
| Phase 1b Dose Expansion | Experimental | Drug: BPT567Study drug BPT567 at recommended dose for expansion (RDE) cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥18 years at the time of signing informed consent form
- Measurable disease per RECIST 1.1
- Histologically- or cytologically-diagnosed, locally advanced unresectable or metastatic solid tumor. Progressed or recurred after previously having received approved standard of care agents that are approved and available in their local geography.
- ECOG Performance status of 0 or 1
- Life expectancy of at least 3 months
Key exclusion criteria (11 listed)
- Has received systemic small molecule therapy or radiation therapy within 28 days prior to the first dose.
- Treatment with biologic agents including anti-PD-1 or PD-L1 antibodies for less than 6 weeks or 5 half-lives, whichever is shorter, prior to first dose.
- Received any investigational agent less than 28 days or 5 half-lives, whichever is shorter, prior to the first dose.
- Treatment with another IL-18 therapy.
- Received systemic immunosuppressive agents greater than the equivalent of prednisone 10mg daily within 14 days of the study, though inhaled, intranasal, topical or intra-articular corticosteroids are allowed.
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 |
|---|---|---|
| BPT567Immunocytokine infusion | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion |
Primary outcome
Incidence of dose limiting toxicity (DLT), Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
Time frame: Duration of first cycle (28 Days) for each cohort evaluated
The MTD will be the highest tested dose of BPT567 at which protocol specified number of patients experience DLT or the MAD, highest administered dose in the absence of DLTs
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through end of study (up to 2 years)
Rate of subjects reporting adverse events or serious adverse events including abnormalities in safety laboratory results
10 secondary outcomes
Pharmacokinetic parameter - Maximum Concentration (Cmax)
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Time to Maximumn Concentration (Tmax)
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Terminal Elimination Half-life (T1/2)
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Area under the plasma concentration curve up to the last quantifiable time-point ((AUC)0-last))
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Pharmacokinetic parameter - Area area under the curve from 0 to infinite time (AUC0-inf)
Time frame: Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)
Anti-drug Antibody (ADA) Response to BPT567
Time frame: Predose and postdose at multiple timepoints up to end of treatment (up to 2 years)
Objective response rate (ORR)
Time frame: Through study completion up to 2 years
Duration of response (DoR)
Time frame: Through study completion up to 2 years
Disease Control Rate (DCR)
Time frame: Through study completion up to 2 years
Progression Free Survival (PFS)
Time frame: Through study completion up to 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPT567 in people with Advanced Solid Tumors, run by Bright Peak Therapeutics Inc at 7 sites in United States.
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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT), Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) (time frame: Duration of first cycle (28 Days) for each cohort evaluated). The study lists 2 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 22 Apr 2026.