RecruitingAdvanced Solid TumorsPlatinum Resistant Ovarian CancerFallopian Tube Cancer
A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors
Sponsor: NextCure, Inc.
You may qualify if…
- ✓ 1. Written informed consent is obtained prior to any procedures that are not considered standard of care.
- ✓ 2. ≥18 years of age.
- ✓ 3. In Part 1:
- ✓ 1. Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard of care therapies.
- ✓ 2. Have progressed on at least one prior systematic anti-tumor regimen, and presence of at least one evaluable lesion according to RECIST Version 1.1. Measurable lesions are required in the backfill period.
- ✓ 3. In the backfill period, eligible tumor types are limited to high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, USC, clear cell RCC, papillary RCC and adenocarcinoma of NSCLC without actionable mutation of epidermal growth factor receptor (EGFR). For participants with NSCLC, presence of CDH6 expression through immunohistochemical examination of tumor tissue by central laboratory is required.
- ✓ 4. In Part 2: Participants must have a diagnosis of specific type of metastatic or locally advanced solid tumors and have progressed on or cannot benefit from the most recent systematic anti-tumor regimen (unless otherwise specified), with presence of at least one measurable lesion according to RECIST Version 1.1.
- ✓ Platinum-resistant ovarian cancer cohort:
You may not qualify if…
- ✕ 1. For Part 2: has clear cell, mucinous or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline ovarian cancer; mixed nonsmall cell and small cell carcinoma, or adenosquamous cell lung cancer with an adenocarcinoma component \<50% (the participant is eligible if the adenocarcinoma component is ≥50%).
- ✕ 2. For Part 2: Participants with primary platinum refractory ovarian cancer, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy.
- ✕ 3. Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.
- ✕ 4. Known untreated CNS metastases and/or leptomeningeal metastases. Participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to the first dose of study treatment. Imaging performed within 28 days prior to the first dose of study treatment must document radiographic stability of CNS lesions and be performed after completion of any CNS-directed therapy.
- ✕ 5. History of bowel obstruction within 3 months prior to the first dose of study treatment.
- ✕ 6. Known psychiatric disorder or drug abuse that would interfere the study requirements.
- ✕ 7. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment.
- ✕ 8. Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment.
Where it's recruiting
Florida
Orlando
Georgia
Atlanta
Louisiana
New Orleans
Massachusetts
Boston
New Jersey
Hackensack
New York
Buffalo · New York
Tennessee
Nashville
Texas
San Antonio
Source: ClinicalTrials.gov · NCT06792552 · last updated 2026-08-17