Solid Tumor, AdultPhase 1/2NCT04902872
Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
A Phase 1/2 study testing CBX-12 in people with Solid Tumor, Adult and Epithelial Ovarian Cancer, run by Cybrexa Therapeutics at 4 sites in United States.
Trial summary
This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, pharmacokinetics (PK), and biomarker study of CBX-12 in subjects with advanced or metastatic refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Epithelial Ovarian Cancer, Small Cell Lung Carcinoma
- What is being tested?
- CBX-12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 May 2021to 24 Jun 2025
- Phase
- Phase 1/2
- 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
- Subject has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists. Subject's prior treatment should include all approved regimens that have demonstrated a survival advantage for the subject's disease, stage, and line of therapy.
- Has measurable disease per RECIST 1.1.
- An adequate tumor sample must be available from core needle biopsies obtained during the Screening Period and following the subject's most recent systemic therapy.
- Agrees to an on-treatment biopsy preferably of the same lesion from which the pre-CBX-12 treatment sample was obtained as long as the Investigator determines such biopsy can be performed with acceptable safety. (Removed Amd 4, date 31-Mar-2023)
Who cannot join
- Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy less than or equal to 3 weeks prior to the first dose of CBX-12. The interval may be reduced to 2 weeks for bone only radiation therapy or investigational agents not expected to be associated with adverse events (AEs) after 2 weeks of last administration, with Medical Monitor approval.
- Small-molecule kinase inhibitors or hormonal agents less than or equal to 14 days prior to the first dose of CBX-12.
- Subjects who are currently receiving any other anti cancer or investigational agent(s).
- Clinically significant intercurrent disease.
- Subjects with primary central nervous system (CNS) tumors or clinically active CNS metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be enrolled with Medical Monitor approval.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
NEXT Oncology
Austin, Texas, 78758
MD Anderson Cancer Center
Houston, Texas, 77030
Yale Cancer Center
New Haven, Connecticut, 06511
NEXT Oncology
San Antonio, Texas, 78229
About this study
Official title: A Phase 1/2 Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, pharmacokinetics (PK), and biomarker study of CBX-12 in subjects with advanced or metastatic refractory solid tumors.
Read the detailed description
Phase 1 is the dose-escalation portion of the study in which the safety and tolerability of three dosing schedules of CBX-12 will be evaluated. Subjects in Part A will be treated with CBX-12 on a daily x 5 every 3 weeks schedule (treatment in Part A was discontinued in October 2021). Subjects in Phase 1 Part B will be treated with CBX-12 on a daily x 3 every 3 weeks schedule. Subjects in Phase 1 Part C will be treated with CBX-12 once weekly. Subjects in Phase 1 Modified Part B will be treated with CBX-12 once every 3 weeks.
For all parts in Phase 1, after all subjects in a cohort have completed treatment through the DLT period or discontinued treatment due to a DLT, the SRC, composed of the Investigators who have enrolled subjects in the current cohort(s), the study Medical Monitor and ad hoc members (e.g., other Investigators, a statistician) as needed, will review all available safety data, including DLTs and all available PK data for that cohort and make dose-level recommendations.
Once the recommended phase 2 dose (RP2D) has been established in Part B, Part C and Modified Part B, Phase 2 expansion cohorts may open.
- Conditions
- Solid Tumor, Adult, Epithelial Ovarian Cancer, Small Cell Lung Carcinoma, Breast Cancer, Colorectal Cancer, Pancreas Cancer
- Being tested
- CBX-12
- Keywords
- SCLC, small cell lung cancer, ovarian, breast, appendix, colorectal, pancreatic, NSCLC, Sarcoma
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Small Cell Lung Carcinoma, Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Appendiceal Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBX-12Drug
CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Schedule B Dose Escalation (Daily Dosing x 3) | Experimental | CBX-12 administered on a daily x 3, 3 week schedule Receives: Drug: CBX-12 |
| Phase 1 Schedule C Dose Escalation (Once Weekly Dosing ) | Experimental | CBX-12 administered once weekly, 4 week schedule Receives: Drug: CBX-12 |
| Phase 2 Ovarian Cancer Expansion Cohort | Experimental | CBX-12 administered TBD Receives: Drug: CBX-12 |
| Phase 2 Metastatic Breast Expansion Cohort | Experimental | CBX-12 administered TBD Receives: Drug: CBX-12 |
| Phase 1 Schedule A Dose Escalation (Daily Dosing x 5) | Experimental | CBX-12 administered on a daily x 5, 3 week schedule Receives: Drug: CBX-12 |
| Phase 1 Modified Schedule B Dose Escalation (Once Every 3 weeks) | Experimental | CBX-12 administered once every 3 weeks Receives: Drug: CBX-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Incidence of treatment-emergent adverse events (TEAEs)
NCI CTCAE v5.0
Measured: Through the end of study, estimated as 6 months
Phase 1: Recommended Phase 2 Dose for Daily x 3 every 3 weeks schedule of CBX-12 (Schedule B)
Safety Review Committee Analysis of Safety and PK Data
Measured: 15 months
Phase 1: Recommended Phase 2 Dose for Once Weekly schedule of CBX-12 (Schedule C)
Safety Review Committee Analysis of Safety and PK Data
Measured: 15 months
Phase 1: Recommended Phase 2 Dose for Once Every 3 Weeks schedule of CBX-12 (Modified Schedule B)
Safety Review Committee Analysis of Safety and PK Data
Measured: 15 months
Phase 2: Overall response rate (ORR)
ORR Based on RECIST v1.1
Measured: Through the end of study, estimated as 6 months
Secondary outcomes (10)
Maximum concentration of CBX-12
PK Analysis
Measured: 5 days
Area under the curve from 0-24 hours of CBX-12
PK Analysis
Measured: 5 days
Time to maximum concentration of CBX-12
PK Analysis
Measured: 5 days
Half-life of CBX-12
PK Analysis
Measured: 5 days
Clearance (CL) of CBX-12
PK Analysis
Measured: 5 days
Apparent Volume of Distribution at Steady State (Vss) CBX-12
PK Analysis
Measured: 5 days
Phase 1: ORR
Based on RECIST v1.1
Measured: Through the end of study, estimated as 6 months
Duration of Response (DoR)
Based on RECIST v1.1
Measured: Through the end of study, estimated as 6 months
Progression-free Survival (PFS)
Based on RECIST v1.1
Measured: Through the end of study, estimated as 6 months
Phase 2: Incidence of TEAEs
NCI CTCAE v5.0
Measured: Through the end of study, estimated as 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start3 May 2021
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Parts B, C \& Modified Part B will follow a 3 + 3 design, enrolling 3 subjects in each cohort. (De)escalation rules: DLT period for each subject in Phase 1 Part B \& Modified Part B will be 3 weeks \& 4 weeks in Part C (i.e., 1 cycle). If none of the 3 subjects experience a DLT, dose will be escalated to next highest dose level. If 1 of 3 subjects in cohort experiences a DLT, up to 3 additional subjects will be enrolled/treated at same dose. If none of the additional 3 subjects experience a DLT (i.e., only 1 of 6 subjects in cohort has a DLT), dose will be escalated to next highest level. If 2 or more of up to 6 subjects at dose level have DLTs, enrollment to that cohort will stop, dose will be considered above MTD. Dose will be decreased to previous dose level or to a level intermediate to those previously evaluated. MTD will be highest dose evaluated at which ≤ 1 of 6 have a DLT. A minimum of 6 DLT-evaluable subjects will be enrolled to any dose level being evaluated as possible MTD.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cybrexa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902872
- Sponsor's protocol ID
- CBX-12-101
- Status last verified
- Aug 2026
- First submitted
- 21 May 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT04902872
- Acronym / sponsor ID
- CBX-12-101
- Conditions
- Solid Tumor, Adult, Epithelial Ovarian Cancer, Small Cell Lung Carcinoma, Breast Cancer, Colorectal Cancer, Pancreas Cancer
- Keywords
- SCLC, small cell lung cancer, ovarian, breast, appendix, colorectal, pancreatic, NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Cybrexa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 26 May 2021 (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 1/2 open-label, multicenter, dose-escalation, safety, pharmacokinetics (PK), and biomarker study of CBX-12 in subjects with advanced or metastatic refractory solid tumors.
Detailed description
Phase 1 is the dose-escalation portion of the study in which the safety and tolerability of three dosing schedules of CBX-12 will be evaluated. Subjects in Part A will be treated with CBX-12 on a daily x 5 every 3 weeks schedule (treatment in Part A was discontinued in October 2021). Subjects in Phase 1 Part B will be treated with CBX-12 on a daily x 3 every 3 weeks schedule. Subjects in Phase 1 Part C will be treated with CBX-12 once weekly. Subjects in Phase 1 Modified Part B will be treated with CBX-12 once every 3 weeks.
For all parts in Phase 1, after all subjects in a cohort have completed treatment through the DLT period or discontinued treatment due to a DLT, the SRC, composed of the Investigators who have enrolled subjects in the current cohort(s), the study Medical Monitor and ad hoc members (e.g., other Investigators, a statistician) as needed, will review all available safety data, including DLTs and all available PK data for that cohort and make dose-level recommendations.
Once the recommended phase 2 dose (RP2D) has been established in Part B, Part C and Modified Part B, Phase 2 expansion cohorts may open.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Parts B, C \& Modified Part B will follow a 3 + 3 design, enrolling 3 subjects in each cohort. (De)escalation rules: DLT period for each subject in Phase 1 Part B \& Modified Part B will be 3 weeks \& 4 weeks in Part C (i.e., 1 cycle). If none of the 3 subjects experience a DLT, dose will be escalated to next highest dose level. If 1 of 3 subjects in cohort experiences a DLT, up to 3 additional subjects will be enrolled/treated at same dose. If none of the additional 3 subjects experience a DLT (i.e., only 1 of 6 subjects in cohort has a DLT), dose will be escalated to next highest level. If 2 or more of up to 6 subjects at dose level have DLTs, enrollment to that cohort will stop, dose will be considered above MTD. Dose will be decreased to previous dose level or to a level intermediate to those previously evaluated. MTD will be highest dose evaluated at which ≤ 1 of 6 have a DLT. A minimum of 6 DLT-evaluable subjects will be enrolled to any dose level being evaluated as possible MTD.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Schedule B Dose Escalation (Daily Dosing x 3) | Experimental | Drug: CBX-12CBX-12 administered on a daily x 3, 3 week schedule |
| Phase 1 Schedule C Dose Escalation (Once Weekly Dosing ) | Experimental | Drug: CBX-12CBX-12 administered once weekly, 4 week schedule |
| Phase 2 Ovarian Cancer Expansion Cohort | Experimental | Drug: CBX-12CBX-12 administered TBD |
| Phase 2 Metastatic Breast Expansion Cohort | Experimental | Drug: CBX-12CBX-12 administered TBD |
| Phase 1 Schedule A Dose Escalation (Daily Dosing x 5) | Experimental | Drug: CBX-12CBX-12 administered on a daily x 5, 3 week schedule |
| Phase 1 Modified Schedule B Dose Escalation (Once Every 3 weeks) | Experimental | Drug: CBX-12CBX-12 administered once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists. Subject's prior treatment should include all approved regimens that have demonstrated a survival advantage for the subject's disease, stage, and line of therapy.
- Has measurable disease per RECIST 1.1.
- An adequate tumor sample must be available from core needle biopsies obtained during the Screening Period and following the subject's most recent systemic therapy.
- Agrees to an on-treatment biopsy preferably of the same lesion from which the pre-CBX-12 treatment sample was obtained as long as the Investigator determines such biopsy can be performed with acceptable safety. (Removed Amd 4, date 31-Mar-2023)
Key exclusion criteria (5 listed)
- Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy less than or equal to 3 weeks prior to the first dose of CBX-12. The interval may be reduced to 2 weeks for bone only radiation therapy or investigational agents not expected to be associated with adverse events (AEs) after 2 weeks of last administration, with Medical Monitor approval.
- Small-molecule kinase inhibitors or hormonal agents less than or equal to 14 days prior to the first dose of CBX-12.
- Subjects who are currently receiving any other anti cancer or investigational agent(s).
- Clinically significant intercurrent disease.
- Subjects with primary central nervous system (CNS) tumors or clinically active CNS metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be enrolled with Medical Monitor approval.
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 |
|---|---|---|
| CBX-12CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety | Drug | Phase 1 Modified Schedule B Dose Escalation (Once Every 3 weeks), Phase 1 Schedule A Dose Escalation (Daily Dosing x 5), Phase 1 Schedule B Dose Escalation (Daily Dosing x 3), Phase 1 Schedule C Dose Escalation (Once Weekly Dosing ), Phase 2 Metastatic Breast Expansion Cohort, Phase 2 Ovarian Cancer Expansion Cohort |
Primary outcome
Phase 1: Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Through the end of study, estimated as 6 months
NCI CTCAE v5.0
Phase 1: Recommended Phase 2 Dose for Daily x 3 every 3 weeks schedule of CBX-12 (Schedule B)
Time frame: 15 months
Safety Review Committee Analysis of Safety and PK Data
Phase 1: Recommended Phase 2 Dose for Once Weekly schedule of CBX-12 (Schedule C)
Time frame: 15 months
Safety Review Committee Analysis of Safety and PK Data
Phase 1: Recommended Phase 2 Dose for Once Every 3 Weeks schedule of CBX-12 (Modified Schedule B)
Time frame: 15 months
Safety Review Committee Analysis of Safety and PK Data
Phase 2: Overall response rate (ORR)
Time frame: Through the end of study, estimated as 6 months
ORR Based on RECIST v1.1
10 secondary outcomes
Maximum concentration of CBX-12
Time frame: 5 days
Area under the curve from 0-24 hours of CBX-12
Time frame: 5 days
Time to maximum concentration of CBX-12
Time frame: 5 days
Half-life of CBX-12
Time frame: 5 days
Clearance (CL) of CBX-12
Time frame: 5 days
Apparent Volume of Distribution at Steady State (Vss) CBX-12
Time frame: 5 days
Phase 1: ORR
Time frame: Through the end of study, estimated as 6 months
Duration of Response (DoR)
Time frame: Through the end of study, estimated as 6 months
Progression-free Survival (PFS)
Time frame: Through the end of study, estimated as 6 months
Phase 2: Incidence of TEAEs
Time frame: Through the end of study, estimated as 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CBX-12 in people with Solid Tumor, Adult and Epithelial Ovarian Cancer, run by Cybrexa Therapeutics at 4 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase 1: Incidence of treatment-emergent adverse events (TEAEs) (time frame: Through the end of study, estimated as 6 months). The study lists 5 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 20 Aug 2026.