Advanced Solid TumorPhase 1/2NCT06685068
A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing GEN1286 in people with Advanced Solid Tumor, run by Genmab at 4 sites in United States.
Trial summary
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in participants with advanced solid tumors. 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?
- GEN1286
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Nov 2024to 30 Mar 2026
- 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
- Participants must be ≥ 18 years of age at the time of informed consent; have measurable disease according to RECIST 1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; adequate organ, bone marrow, liver, coagulation, and renal function; and be willing to provide a pretreatment tumor specimen.
- All participants must have pathologically confirmed diagnosis of advanced solid tumor.
- Participants must have metastatic or unresectable locally advanced, recurrent disease not amenable to further local therapy and must have previously received therapies known to confer clinical benefit (unless ineligible to receive, refused to receive, or therapy is unavailable in the region).
Who cannot join
- Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
START Midwest
Grand Rapids, Michigan, 49546
START San Antonio
San Antonio, Texas, 78229
START Mountain Region
West Valley City, Utah, 84119
About this study
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in participants with advanced solid tumors.
This trial consists of 2 parts:
- Part A: Dose escalation and dose level expansion
- Part B: Tumor-specific expansion with dose optimization
- Conditions
- Advanced Solid Tumor
- Being tested
- GEN1286
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN1286Drug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| GEN1286 | Experimental | Not described Receives: Drug: GEN1286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: From first dose until 12 months post last dose of study drug or withdrawal of consent, death, or study closure, whichever occurs first (Up to approximately 3 years 9 months)
Number of Participants With Dose Limiting Toxicities (DLTs)
Toxicities will be graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
Measured: During first cycle (Cycle length=21 days)
Secondary outcomes (9)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants achieving a partial response (PR) or complete response (CR) as assessed by the investigator based on response evaluation criteria in solid tumors (RECIST) version 1.1.
Measured: Up to approximately 3 years 9 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with stable disease (SD) or achieving a PR or CR based on RECIST version 1.1 as assessed by the investigator.
Measured: Up to approximately 3 years 9 months
Progression Free Survival (PFS)
PFS is defined as the time from the start of any treatment to the date of the first documented progression or death due to any cause, whichever occurs first based on RECIST version 1.1 as assessed by the investigator.
Measured: Up to approximately 3 years 9 months
Duration of Objective Response (DOR)
DOR is defined as the time from the first documentation of an objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first based on RECIST version 1.1 as assessed by the investigator.
Measured: Up to approximately 3 years 9 months
Area Under the Plasma or Serum Concentration Time Curve (AUC) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Total Antibody (Tab) and u-Exatecan
Measured: Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days)
Maximum Observed Plasma or Serum Concentration (Cmax) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Tab and u-Exatecan
Measured: Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days)
Apparent Terminal Half-life (t1/2) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Tab and u-Exatecan
Measured: Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days)
Trough Concentrations (Ctrough) of GEN1286 Related Analytes- Antibody-conjugated Exatecan, Tab and u-Exatecan
Measured: Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days)
Number of Participants with Antidrug Antibodies (ADA) to GEN1286
Measured: Up to approximately 2 years 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start13 Nov 2024
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Why it stopped: Genmab has decided to terminate the GEN1286 program due to an unfavorable benefit-risk profile not supporting further development.
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.
- More trials run by GenmabThe sponsor's other registered studies.
- 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
- No randomization will be performed in Part A (dose escalation- sequential assignment). In Part B (tumor-specific expansion- parallel assignment), participants in each cohort will be randomized with a 1:1 ratio to receive one of the expansion doses of GEN1286.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685068
- Sponsor's protocol ID
- GCT1286-01
- Other IDs
- CTR20250215, PRO1286-001
- Status last verified
- Jul 2026
- First submitted
- 11 Nov 2024
- Last updated
- 13 Jul 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06685068
- Acronym / sponsor ID
- GCT1286-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Genmab has decided to terminate the GEN1286 program due to an unfavorable benefit-risk profile not supporting further development.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 12 Nov 2024 (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 purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in participants with advanced solid tumors.
This trial consists of 2 parts:
- Part A: Dose escalation and dose level expansion
- Part B: Tumor-specific expansion with dose optimization
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- No randomization will be performed in Part A (dose escalation- sequential assignment). In Part B (tumor-specific expansion- parallel assignment), participants in each cohort will be randomized with a 1:1 ratio to receive one of the expansion doses of GEN1286.
| Arm | Type | Receives |
|---|---|---|
| GEN1286 | Experimental | Drug: GEN1286 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be ≥ 18 years of age at the time of informed consent; have measurable disease according to RECIST 1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; adequate organ, bone marrow, liver, coagulation, and renal function; and be willing to provide a pretreatment tumor specimen.
- All participants must have pathologically confirmed diagnosis of advanced solid tumor.
- Participants must have metastatic or unresectable locally advanced, recurrent disease not amenable to further local therapy and must have previously received therapies known to confer clinical benefit (unless ineligible to receive, refused to receive, or therapy is unavailable in the region).
Key exclusion criteria (2 listed)
- Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
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 |
|---|---|---|
| GEN1286Specified dose on specified days. | Drug | GEN1286 |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: From first dose until 12 months post last dose of study drug or withdrawal of consent, death, or study closure, whichever occurs first (Up to approximately 3 years 9 months)
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: During first cycle (Cycle length=21 days)
Toxicities will be graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 3 years 9 months
Disease Control Rate (DCR)
Time frame: Up to approximately 3 years 9 months
Progression Free Survival (PFS)
Time frame: Up to approximately 3 years 9 months
Duration of Objective Response (DOR)
Time frame: Up to approximately 3 years 9 months
Area Under the Plasma or Serum Concentration Time Curve (AUC) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Total Antibody (Tab) and u-Exatecan
Time frame: Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days)
Maximum Observed Plasma or Serum Concentration (Cmax) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Tab and u-Exatecan
Time frame: Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days)
Apparent Terminal Half-life (t1/2) of GEN1286 Related Analytes- Antibody-Conjugated Exatecan, Tab and u-Exatecan
Time frame: Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days)
Trough Concentrations (Ctrough) of GEN1286 Related Analytes- Antibody-conjugated Exatecan, Tab and u-Exatecan
Time frame: Predose and postdose at multiple timepoints at end of each cycle, up to approximately 2 years 9 months (Cycle length=21 days)
Number of Participants with Antidrug Antibodies (ADA) to GEN1286
Time frame: Up to approximately 2 years 9 months
Results and safety
The study was stopped early (reason given: Genmab has decided to terminate the GEN1286 program due to an unfavorable benefit-risk profile not supporting further development.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.
Study Official study director
Genmab
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 GEN1286 in people with Advanced Solid Tumor, run by Genmab 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 3 inclusion and 2 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 13 Jul 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 was stopped early (reason given: Genmab has decided to terminate the GEN1286 program due to an unfavorable benefit-risk profile not supporting further development.). 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?
Number of Participants With Adverse Events (AEs) (time frame: From first dose until 12 months post last dose of study drug or withdrawal of consent, death, or study closure, whichever occurs first (Up to approximately 3 years 9 months)). 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 13 Jul 2026.