Colorectal CancerPhase 1NCT07578571
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
A Phase 1 study testing IM-1617 in people with Colorectal Cancer and Non-Small Cell Lung Cancer, run by Immunome, Inc. at 5 sites in United States.
Trial summary
This study will test the safety and effectiveness of a drug called IM-1617 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, Breast Cancer
- What is being tested?
- IM-1617
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 May 2026to Jan 2029
- 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, or 2
- Part A: Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
- CRC, all subtypes
- NSCLC:
- Non-squamous cell carcinoma subtypes, such as adenocarcinoma
- Squamous cell carcinoma subtype
Show all 33Show fewer
- Breast cancer (subtypes based on estrogen/progesterone receptor and HER2 testing according to American Society of Clinical Oncology - College of American Pathologists guidelines):
- Triple-negative breast cancer
- HR+, HER2- subtype
- Esophageal, esophagogastric junction, and gastric cancer:
- Adenocarcinoma subtype
- Other histologies, if approved by the Medical Monitor, which may include: head and neck squamous cell carcinoma; cervical cancer; bladder cancer; squamous cell carcinoma subtype of esophageal, esophagogastric junction, and gastric cancer; HER2+ breast cancer
- Part B Cohorts - Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
- Cohort B1: CRC, all subtypes
- Cohort B2: NSCLC
- Non-squamous cell carcinoma subtypes, such as adenocarcinoma
- Squamous cell carcinoma subtype
- Cohorts B3 and B4: Cohort-specific disease indications may include those listed for Part A
- Participants must have disease that is considered to be noncurative and meet the appropriate criteria below:
- Part A only: Participants have progressed on, were intolerant to, or have a contraindication to prior SOC treatments, with no satisfactory SOC treatment options available.
- Part B only:
- Cohort B1 (CRC):
- Participants must have previously progressed on, were intolerant to, or have a contraindication to fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, bevacizumab, and for those with RAS wild-type tumors, an anti-epidermal growth factor receptor (EGFR)-directed monoclonal antibody in advanced disease setting.
- Participants with actionable biomarkers must have been treated with at least one prior appropriate biomarker-directed therapy.
- If any of these therapies were given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.
- Participants must not have received more than 3 prior lines of systemic therapy (excluding targeted therapies for actionable biomarkers).
- Cohort B2 (NSCLC):
- Participants must have previously progressed on, were intolerant to, or have a contraindication to platinum-based chemotherapy and a programmed cell death-1 (PD-1)/programmed death ligand 1 (PD-L1) monoclonal antibody (given concurrently or sequentially with chemotherapy) in advanced disease setting.
- Participants with actionable biomarkers must have been treated with at least one prior appropriate targeted therapy.
- If any of these therapies were given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.
- Participants must not have received more than 2 prior lines of systemic therapy (excluding targeted therapies for actionable biomarkers).
- Cohorts B3 and B4: Criteria will be specified based on the disease indications selected.
- Participants must have measurable disease as defined per RECIST v1.1
Who cannot join
- Previously treated with an antibody-drug conjugate (ADC) with a topoisomerase-1 (TOP1) inhibitor payload. Exception: Participants with NSCLC or breast cancer may have received up to one prior ADC with a TOP1 inhibitor payload
- History of anaphylactic reaction to TOP1 inhibitors (e.g., irinotecan) or TOP1 inhibiting ADCs
- Life expectancy < 12 weeks
- Prior solid organ transplant
- Symptomatic ascites or pleural effusion
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Known history of another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone definitive/curative therapy, has had no evidence of recurrence and has negligible risk of metastatic disease of death, with approval by the Medical Monitor
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
NEXT Dallas
Irving, Texas, 75039
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06520
- Recruiting
Florida Cancer Specialists & Research Institute - Sarasota Cattlemen
Sarasota, Florida, 34239
About this study
Official title: A Phase 1 Study of IM-1617 in Participants With Advanced Malignancies
This study will test the safety and effectiveness of a drug called IM-1617 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-1617 to find out the safe dose and schedule of IM-1617 for participants. Part B will use the dose and schedule found in Part A to further study the safety of IM-1617 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-1617 administered to participants with unresectable locally advanced or metastatic solid tumors. The study consists of 2 parts:
Part A: A dose-escalation phase to evaluate the safety and tolerability of IM-1617 to determine the recommended dose for expansion (RDE), evaluate maximum tolerated dose, and maximum achievable dose of IM-1617.
Part B: An expansion phase to further evaluate the safety and preliminary antitumor activity of IM-1617 monotherapy at the RDE and one or more other dose regimens in up to 4 indication-specific cohorts.
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer, Breast Cancer, Esophageal Cancer, Stomach Cancer, Cancer
- Being tested
- IM-1617
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM-1617Drug
IM-1617 is an antibody-drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| IM-1617 Dose Escalation | Experimental | IM-1617 given into the vein (IV; intravenously) Receives: Drug: IM-1617 |
| IM-1617 Monotherapy Dose Expansion | Experimental | IM-1617 given into the vein (IV; intravenously) Receives: Drug: IM-1617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of adverse events (AEs) and serious adverse events (SAEs)
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of AEs of interest (AEIs)
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of AEs leading to discontinuation
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of death
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Measured: Through 30 days after last dose of study treatment; approximately 12 months
Secondary outcomes (7)
Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic 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-1617 in participants with unresectable locally advanced or metastatic 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-1617 in participants with unresectable locally advanced or metastatic 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-1617 in participants with unresectable locally advanced or metastatic 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-1617
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-1617 in participants with unresectable locally advanced or metastatic 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-1617 in participants with unresectable locally advanced or metastatic solid tumors
Disease Control Rate (DCR) 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start21 May 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (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
- NCT07578571
- Sponsor's protocol ID
- IM-1617-101
- Status last verified
- Oct 2026
- First submitted
- 5 May 2026
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of IM-1617 in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT07578571
- Acronym / sponsor ID
- IM-1617-101
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer, Breast Cancer, Esophageal Cancer, Stomach Cancer, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Immunome, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 11 May 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-1617 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-1617 to find out the safe dose and schedule of IM-1617 for participants. Part B will use the dose and schedule found in Part A to further study the safety of IM-1617 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-1617 administered to participants with unresectable locally advanced or metastatic solid tumors. The study consists of 2 parts:
Part A: A dose-escalation phase to evaluate the safety and tolerability of IM-1617 to determine the recommended dose for expansion (RDE), evaluate maximum tolerated dose, and maximum achievable dose of IM-1617.
Part B: An expansion phase to further evaluate the safety and preliminary antitumor activity of IM-1617 monotherapy at the RDE and one or more other dose regimens in up to 4 indication-specific cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IM-1617 Dose Escalation | Experimental | Drug: IM-1617IM-1617 given into the vein (IV; intravenously) |
| IM-1617 Monotherapy Dose Expansion | Experimental | Drug: IM-1617IM-1617 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 (33 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Part A: Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
- Part B Cohorts - Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
- Participants must have disease that is considered to be noncurative and meet the appropriate criteria below:
- Participants must have measurable disease as defined per RECIST v1.1
Key exclusion criteria (7 listed)
- Previously treated with an antibody-drug conjugate (ADC) with a topoisomerase-1 (TOP1) inhibitor payload. Exception: Participants with NSCLC or breast cancer may have received up to one prior ADC with a TOP1 inhibitor payload
- History of anaphylactic reaction to TOP1 inhibitors (e.g., irinotecan) or TOP1 inhibiting ADCs
- Life expectancy < 12 weeks
- Prior solid organ transplant
- Symptomatic ascites or pleural effusion
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-1617IM-1617 is an antibody-drug conjugate | Drug | IM-1617 Dose Escalation, IM-1617 Monotherapy Dose Expansion |
Primary outcome
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of adverse events (AEs) and serious adverse events (SAEs)
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 (NCI-CTCAE) version 6.0
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of AEs of interest (AEIs)
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 (NCI-CTCAE) version 6.0
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of AEs leading to discontinuation
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 (NCI-CTCAE) version 6.0
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of death
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 (NCI-CTCAE) version 6.0
7 secondary outcomes
Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic 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-1617 in participants with unresectable locally advanced or metastatic 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-1617 in participants with unresectable locally advanced or metastatic 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-1617 in participants with unresectable locally advanced or metastatic 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-1617
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the preliminary antitumor activity of IM-1617 in participants with unresectable locally advanced or metastatic 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-1617 in participants with unresectable locally advanced or metastatic 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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 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 IM-1617 in people with Colorectal Cancer and Non-Small Cell Lung Cancer, run by Immunome, Inc. at 5 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 33 inclusion and 7 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Through 30 days after last dose of study treatment; approximately 12 months). The study lists 4 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 3 Nov 2026.