NCT07890246Toborzás még nem indult1. fázis
A Phase 1 Study of IM-1340 in Participants With Advanced Cancer
A Phase 1 Study of IM-1340 in Participants With Advanced Malignancies
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 22.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 200 (tervezett)
- Első benyújtás
- 2026. okt. 16.
- Kezdés
- 2026. nov.
- Elsődleges befejezés
- 2030. szept.
- Fő szponzor
- Immunome, Inc.
- Betegségek
- Vastagbélrák, Tüdőrák, Neuroendokrin daganatok
- NCT-szám
- NCT07890246
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 200
- 2026. nov. és az elsődleges befejezés (2030. szept.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
Más betegség
- 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.
Egyéb
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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