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Not yet recruitingNCT07890246Updated Oct 22, 2026

A Phase 1 Study of IM-1340 in Participants With Advanced Cancer

A Phase 1 interventional study of IM-1340 in Colorectal Cancer, Non-Small Cell Lung Cancer and Small Cell Lung Cancer, sponsored by Immunome, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Immunome, Inc. · Phase 1, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Colorectal Cancer
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Neuroendocrine Neoplasm
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 200 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Immunome, Inc. is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Immunome, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)
      • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    IM-1340 Dose Escalation

    IM-1340 given into the vein (IV; intravenously)

    Drug: IM-1340

  • Experimental
    IM-1340 Monotherapy Dose Expansion

    IM-1340 given into the vein (IV; intravenously)

    Drug: IM-1340

Interventions

  • DrugIM-1340

    IM-1340 is an antibody-drug conjugate (ADC)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

Secondary outcomes

  1. Characterize the PK of IM-1340 in participants with advanced solid tumors by area under the concentration-time curve (AUC)

    Pharmacokinetic (PK) parameter

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  2. Characterize the PK of IM-1340 in participants with advanced solid tumors by maximum observed concentration (Cmax)

    PK parameter

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  3. Characterize the PK of IM-1340 in participants with advanced solid tumors by time to maximum observed concentration (Tmax)

    PK parameter

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  4. Characterize the PK of IM-1340 in participants with advanced solid tumors by trough concentration (Ctrough)

    PK parameter

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  5. Characterize the immunogenicity of IM-1340

    Incidence of antidrug antibodies (ADA)

    Time frame: Through 30 days after last dose of study treatment; approximately 12 months

  6. 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

    Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months

  7. 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

    Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Sep 2030, 46 months later.

Of 201 industry-sponsored phase 1 interventional studies under Colorectal Neoplasms, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 67. This study's planned 46 months is close to that.

Counting every sponsor, half of 342 studies reached it within 49 months; a quarter within 32 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2026
First posted
Oct 22, 2026
StartEst.
Nov 2026
Primary completionEst.
Sep 2030
CompletionEst.
Sep 2030
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07890246
Lead sponsor
Immunome, Inc.
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Nov 2026 (estimated)
Primary completion
Sep 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Oct 22, 2026

Study contacts

Immunome Medical Monitor
Contact
info@immunome.com
800-811-4074

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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