Colorectal CancerPhase 1NCT07890246
A Phase 1 Study of IM-1340 in Participants With Advanced Cancer
A Phase 1 study testing IM-1340 in people with Colorectal Cancer and Non-Small Cell Lung Cancer, run by Immunome, Inc..
Trial summary
This study will test the safety and effectiveness of a drug called IM-1340 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have two parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Non-Small Cell Lung Cancer, Small Cell Lung Cancer
- What is being tested?
- IM-1340
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Sep 2030
- Phase
- Phase 1
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
- Histological diagnosis including but not limited to one of the following advanced solid tumors:
- Part A
- Extended stage small cell lung cancer (ES-SCLC)
- High-grade neuroendocrine neoplasms (NENs)
- G3 neuroendocrine tumor (NET) and neuroendocrine carcinoma (NEC, pulmonary and extrapulmonary)
Show all 24Show fewer
- Non-squamous non-small cell lung cancer (NSCLC)
- Colorectal cancer
- Part B
- Cohort B1: ES-SCLC
- Cohort B2: Non-squamous NSCLC
- Other Part B cohorts: Cohort-specific disease indication may include those listed under Part A above
- Participants must have disease that is considered to be incurable and meet the appropriate criteria below:
- Part A:
- ES-SCLC: Participants must have received, or be ineligible to receive, prior platinum-based chemotherapy and a programmed cell death-1/programmed death-ligand 1 (PD-[L]1) monoclonal antibody.
- Other tumor types, with Medical Monitor approval: Participants must have received, or be ineligible to receive, available SOC treatments, or have no satisfactory SOC treatment options available.
- Part B:
- Cohort B1 (ES-SCLC):
- Participants must have received, or be ineligible to receive, prior platinum-based chemotherapy and a PD-[L]1 monoclonal antibody.
- Cohort B2 (non-sq NSCLC):
- Participants must have previously received, or be ineligible to receive, platinum-based chemotherapy and a PD-[L]1 monoclonal antibody. Participants with a known actionable biomarker(s) must have been treated with at least one prior appropriate available targeted therapy.
- Other Part B cohorts: Criteria will be specified based on the disease indications selected.
- Participants must have measurable disease as per RECIST v1.1
- Participants must have adequate organ function.
Who cannot join
- Previously treated with an ADC with a DNA topoisomerase inhibitor (TOP1) payload
- Note: Participants with non-squamous NSCLC who have received up to one prior ADC with a TOP1 inhibitor payload are eligible. Participants with other tumor types previously treated with an ADC with a TOP1 inhibitor payload may be eligible if approved by the Medical Monitor.
- History of an anaphylactic reaction to TOP1 inhibitors or TOP1-inhibiting ADCs.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Known history of another primary malignancy, unless the participant has undergone potentially curative therapy with no evidence of recurrence and/or negligible risk of metastatic disease and death and consulted with the Medical Monitor.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Study of IM-1340 in Participants With Advanced Malignancies
This study will test the safety and effectiveness of a drug called IM-1340 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have two parts. Part A will test increasing doses of IM-1340 to find out the safe dose and schedule of IM-1340 for participants. Part B will use the dose and schedule found in Part A to further study the safety of IM-1340 and if it works to treat solid tumor cancers.
Read the detailed description
This is a Phase 1 open-label, multicenter, dose escalation and expansion study designed to determine the safety, tolerability, PK, and preliminary antitumor activity of IM-1340 administered to participants with advanced solid tumors. The study consists of 2 parts:
Part A: A dose-escalation phase to evaluate the safety and tolerability of IM-1340 to determine the recommended dose for expansion (RDE) and evaluate maximum tolerated dose (MTD) and/or maximum achievable dose.
Part B: An expansion phase to further evaluate the safety and preliminary antitumor activity of IM-1340 monotherapy.
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Neuroendocrine Neoplasm
- Being tested
- IM-1340
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM-1340Drug
IM-1340 is an antibody-drug conjugate (ADC)
| Study group | Role | What they receive |
|---|---|---|
| IM-1340 Dose Escalation | Experimental | IM-1340 given into the vein (IV; intravenously) Receives: Drug: IM-1340 |
| IM-1340 Monotherapy Dose Expansion | Experimental | IM-1340 given into the vein (IV; intravenously) Receives: Drug: IM-1340 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of IM-1340 in participants with advanced solid tumors
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0, including serious adverse events, AEs of interest, AEs leading to treatment discontinuation, and deaths.
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Secondary outcomes (7)
Characterize the PK of IM-1340 in participants with advanced solid tumors by area under the concentration-time curve (AUC)
Pharmacokinetic (PK) parameter
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1340 in participants with advanced solid tumors by maximum observed concentration (Cmax)
PK parameter
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1340 in participants with advanced solid tumors by time to maximum observed concentration (Tmax)
PK parameter
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1340 in participants with advanced solid tumors by trough concentration (Ctrough)
PK parameter
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the immunogenicity of IM-1340
Incidence of antidrug antibodies (ADA)
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the preliminary antitumor activity of IM-1340 in participants with advanced solid tumors
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator
Measured: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months
Evaluate the preliminary antitumor activity of IM-1340 in participants with advanced solid tumors
Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator
Measured: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunome, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890246
- Sponsor's protocol ID
- IM-1340-101
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of IM-1340 in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT07890246
- Acronym / sponsor ID
- IM-1340-101
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Neuroendocrine Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Immunome, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 22 Oct 2026 (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 study will test the safety and effectiveness of a drug called IM-1340 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have two parts. Part A will test increasing doses of IM-1340 to find out the safe dose and schedule of IM-1340 for participants. Part B will use the dose and schedule found in Part A to further study the safety of IM-1340 and if it works to treat solid tumor cancers.
Detailed description
This is a Phase 1 open-label, multicenter, dose escalation and expansion study designed to determine the safety, tolerability, PK, and preliminary antitumor activity of IM-1340 administered to participants with advanced solid tumors. The study consists of 2 parts:
Part A: A dose-escalation phase to evaluate the safety and tolerability of IM-1340 to determine the recommended dose for expansion (RDE) and evaluate maximum tolerated dose (MTD) and/or maximum achievable dose.
Part B: An expansion phase to further evaluate the safety and preliminary antitumor activity of IM-1340 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IM-1340 Dose Escalation | Experimental | Drug: IM-1340IM-1340 given into the vein (IV; intravenously) |
| IM-1340 Monotherapy Dose Expansion | Experimental | Drug: IM-1340IM-1340 given into the vein (IV; intravenously) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
- Histological diagnosis including but not limited to one of the following advanced solid tumors:
- Participants must have disease that is considered to be incurable and meet the appropriate criteria below:
- Participants must have measurable disease as per RECIST v1.1
- Participants must have adequate organ function.
Key exclusion criteria (5 listed)
- Previously treated with an ADC with a DNA topoisomerase inhibitor (TOP1) payload
- History of an anaphylactic reaction to TOP1 inhibitors or TOP1-inhibiting ADCs.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Known history of another primary malignancy, unless the participant has undergone potentially curative therapy with no evidence of recurrence and/or negligible risk of metastatic disease and death and consulted with the Medical Monitor.
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 |
|---|---|---|
| IM-1340IM-1340 is an antibody-drug conjugate (ADC) | Drug | IM-1340 Dose Escalation, IM-1340 Monotherapy Dose Expansion |
Primary outcome
Evaluate the safety and tolerability of IM-1340 in participants with advanced solid tumors
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0, including serious adverse events, AEs of interest, AEs leading to treatment discontinuation, and deaths.
7 secondary outcomes
Characterize the PK of IM-1340 in participants with advanced solid tumors by area under the concentration-time curve (AUC)
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1340 in participants with advanced solid tumors by maximum observed concentration (Cmax)
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1340 in participants with advanced solid tumors by time to maximum observed concentration (Tmax)
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1340 in participants with advanced solid tumors by trough concentration (Ctrough)
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the immunogenicity of IM-1340
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the preliminary antitumor activity of IM-1340 in participants with advanced solid tumors
Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months
Evaluate the preliminary antitumor activity of IM-1340 in participants with advanced solid tumors
Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months
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 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IM-1340 in people with Colorectal Cancer and Non-Small Cell Lung Cancer, run by Immunome, Inc..
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 24 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: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Immunome Medical Monitor (800-811-4074, info@immunome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of IM-1340 in participants with advanced solid tumors (time frame: Through 30 days after last dose of study treatment; approximately 12 months). 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 Oct 2026.