Actively Recruiting
A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors
Led by NextCure, Inc. · Updated on 2026-01-29
414
Participants Needed
17
Research Sites
178 weeks
Total Duration
On this page
Sponsors
N
NextCure, Inc.
Lead Sponsor
S
Shanghai Xianxiang Medical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before non-standard procedures
- 18 years of age or older
- For Part 1: Participants with confirmed advanced solid tumors who have failed or are ineligible for standard treatments
- Have progressed on at least one prior anti-tumor treatment and have at least one measurable lesion
- For the backfill period, eligible tumor types include high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, uterine serous carcinoma, clear cell and papillary renal cell carcinoma, and non-small cell lung cancer without actionable EGFR mutation
- For NSCLC participants, tumor tissue must show CDH6 expression
- For Part 2: Participants with specific metastatic or locally advanced solid tumors who have progressed or cannot benefit from recent treatments, with measurable lesions
- Specific cohorts include platinum-resistant ovarian cancer, renal cell carcinoma, uterine serous carcinoma, and non-small cell lung cancer with CDH6 expression
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function per protocol laboratory values
- Women of childbearing potential must have a negative pregnancy test within 72 hours before treatment start
- Participants must use effective contraception and agree to avoid sperm/egg donation from consent through 180 days after last dose
- Must provide tumor tissue sample not previously irradiated for CDH6 testing
You will not qualify if you...
- For Part 2: Clear cell, mucinous, sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline ovarian cancer; mixed non-small cell and small cell carcinoma or adenosquamous cell lung cancer with less than 50% adenocarcinoma component
- Any other malignancy within 2 years prior to study treatment except low-risk localized cancers
- Symptomatic central nervous system metastases or those requiring local therapy or corticosteroids within 2 weeks before treatment
- History of bowel obstruction within 3 months before treatment
- Known psychiatric disorder or drug abuse interfering with study requirements
- Uncontrolled pleural, pericardial effusion, or ascites requiring drainage within 4 weeks before treatment
- Active infection requiring intravenous treatment within 2 weeks before treatment
- History of non-infectious pneumonitis requiring steroids, interstitial lung disease, or severe obstructive pulmonary disease
- Prior exposure to CDH6-targeted agents or ADC with topoisomerase I inhibitor payload
- Major surgery within 2 weeks before treatment
- Recent prior anti-cancer therapies within specified time frames before treatment
- Use of live vaccine therapy within 4 weeks before treatment
- Use of strong/moderate CYP3A4 inhibitors or drugs with Torsades de Pointes risk within 14 days before treatment
- Known HIV infection or AIDS
- Active hepatitis B or C infection
- Significant cardiovascular diseases
- History of allogeneic organ transplantation or graft-versus-host disease
- Known hypersensitivity to the study drug or its ingredients
- Currently pregnant or breastfeeding
- Other conditions deemed inappropriate by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Sarah Cannon Research Institute (SCRI) - Lake Nona
Orlando, Florida, United States, 32827
Actively Recruiting
2
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
University Medical Center of New Orleans LSU-LCMC Health Cancer Center
New Orleans, Louisiana, United States, 70112
Not Yet Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
7
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10128
Actively Recruiting
8
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
UT Health San Antonio - Mays Cancer Center
San Antonio, Texas, United States, 78229
Actively Recruiting
10
The first medical center of PLA general hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
11
Liaoning Cancer Hospital & Institute
Shenyang, China, China, 110092
Not Yet Recruiting
12
The Fourth Hospital of Hebei Medical University (Heibei Tumor Hospital)
Shijiazhuang, China, China, 050010
Not Yet Recruiting
13
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
14
HunanCancer Hospital
Changsha, Hunan, China, 430100
Actively Recruiting
15
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
16
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272000
Actively Recruiting
17
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
U
Udayan Guha, PhD, MD
CONTACT
S
Siyuan Qian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here