Recruiting

SIM0505 for Advanced Solid Tumors

What is being tested

SIM0505 for injection

Drug

Who is being recruted

Over 18 Years

+36 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: February 2025

See protocol details

Summary

Principal SponsorNextCure, Inc.

Study ContactUdayan Guha, PhD, MDMore contacts

Last updated: January 30, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 26, 2025

Actual date on which the first participant was enrolled.

This clinical trial is a phase 1 study focusing on the safety and initial effectiveness of a new drug called SIM0505. The trial is designed for adults who have advanced solid tumors, which are complex and serious types of cancer. The main goal is to determine whether SIM0505 is safe and tolerable for patients, and to see how the drug behaves in the body. Additionally, researchers are looking to identify any signs that SIM0505 might help in fighting these tumors, which could lead to advancements in cancer treatment. Participants in the study will receive SIM0505, and the way it is administered will be specified by the research team. The study involves closely monitoring the participants to gather data on how the drug is absorbed, distributed, and processed by the body. Researchers will also look for any side effects and measure any changes in the tumors. This information will help determine the best dose and further understand the potential of SIM0505 as a cancer treatment. Safety is a top priority, and all participants will be carefully observed throughout the study.

Official TitleA Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors

NCT06792552

Principal SponsorNextCure, Inc.

Study ContactUdayan Guha, PhD, MDMore contacts

Last updated: January 30, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

414 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

16 inclusion criteria required to participate

Women of childbearing potential (WOCBP)must have a negative serum pregnancy test within 72 hours prior to the start of study treatment. WOCBP or male participants are required to use highly effective contraceptive methods , and agree to refrain from donating sperm/egg from signing of informed consent through 180 days after the last dose of study treatment.

Participants with histologically- or cytologically-confirmed clear cell RCC or papillary RCC.

Participants with histologically or cytologically confirmed high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Have adequate organ function as indicated by the laboratory values listed within the protocol.

Show More Criteria

20 exclusion criteria prevent from participating

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%).

Participants with clinically significant cardiovascular diseases.

Prior exposure to other CDH6-targeted agents or an ADC with a topoisomerase I inhibitor payload (e.g., raludotatug deruxtecan/DS-6000).

History of bowel obstruction within 3 months prior to the first dose of study treatment.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Every 21 days is one cycle. Multiple dose levels of SIM0505 will be explored in dose escalation, and determine the maximum tolerated dose.

Group II

Experimental

Every 21 days is one cycle. 2 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in lung cancer.

Group III

Experimental

Every 21 days is one cycle. 2-3 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in ovarian cancer.

Group IV

Experimental

Group 5

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

Recruiting

Sarah Cannon Research Institute (SCRI) - Lake Nona

Orlando, United StatesOpen Sarah Cannon Research Institute (SCRI) - Lake Nona in Google Maps

Recruiting

Emory Winship Cancer Institute

Atlanta, United States

Recruiting

Dana-Farber Cancer Institute

Boston, United States

Recruiting

Hackensack University Medical Center

Hackensack, United States

Recruiting

17 Study Centers