NCT07890246Not yet recruitingPhase 1
A Phase 1 Study of IM-1340 in Participants With Advanced Cancer
A Phase 1 Study of IM-1340 in Participants With Advanced Malignancies
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Sept 2030
- Lead sponsor
- Immunome, Inc.
- NCT number
- NCT07890246
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 200
- From Nov 2026 to the primary completion date, Sept 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of an anaphylactic reaction to TOP1 inhibitors or TOP1-inhibiting ADCs.
- 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.
Other
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.