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Advanced Solid TumorsPhase 1NCT06792552

A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors

A Phase 1 study testing SIM0505 for injection in people with Advanced Solid Tumors and Platinum Resistant Ovarian Cancer, run by NextCure, Inc. at 17 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SIM0505 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
738 participants
Where
17 sitesin 2 countries
Study dates
26 Feb 2025to Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent is obtained prior to any procedures that are not considered standard of care.
  • ≥18 years of age.
  • In Part 1:
  • Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard of care therapies.
  • 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.
  • 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.
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  • 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:
  • Participants with histologically or cytologically confirmed high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • Have platinum-resistant disease, defined as: participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a best response of CR or PR, and then progressed between >90 days and ≤180 days after the date of the last dose of platinum; participants who have received ≥2 lines of platinum therapy must have progressed ≤180 days after the date of the last dose of platinum.
  • At least one line of therapy containing anti-VEGF therapy (e.g., bevacizumab or suvemcitug or their biosimilar), unless the participant is not eligible for treatment with anti- angiogenic treatment due to precautions/intolerance. Has had prior poly-ADP ribose polymerase (PARP) inhibitors for subjects with documented breast cancer gene (BRCA) mutation (germline and/or somatic), unless the subject is not eligible for treatment with a PARP inhibitor. Has had prior treatment with mirvetuximab soravtansine for participants with documented high folate receptor alpha expression, unless the subject is not eligible for treatment with mirvetuximab soravtansine due to precautions/intolerance, or if the treatment is not approved or available locally. In the PROC cohort, topoisomerase inhibitor payload ADC-pretreated participants should have received at least one prior topoisomerase inhibitor payload ADC.
  • Renal cell carcinoma cohort:
  • Participants with histologically- or cytologically-confirmed clear cell RCC or papillary RCC.
  • For clear cell RCC: Participants who have progressed on or after systemic treatment including a programmed cell death protein 1 or programmed death ligand 1 (PD-1/PD-L1) checkpoint inhibitor and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI), either given concurrently or in separate lines of therapy.
  • For papillary RCC: Participants without any prior systemic treatment is acceptable.
  • Uterine serous carcinoma cohort:
  • Participants with histologically- or cytologically-confirmed USC.
  • Have progressed on or after systemic treatment that contained platinum-based chemotherapy.
  • Non-Small Cell Lung Cancer cohort:
  • Participants with histologically- or cytologically-confirmed adenocarcinoma of NSCLC without actionable mutation of EGFR.
  • Presence of CDH6 expression through immunohistochemical examination of tumor tissue.
  • For participants without actionable mutations: Have progressed on or after systemic treatment including anti-PD-1/PD-L1 antibody and platinum-based chemotherapy, either given concurrently or in separate lines of therapy. Progression within 6 months after completion of adjuvant therapy is considered failure of first-line therapy.
  • For participants with actionable mutations other than EGFR: Have failed at least one established standard anti-cancer targeted therapy, anti-PD-1/PD-L1 antibody and platinum-based chemotherapy (PD-1/PD-L1 and chemotherapy either given concurrently or in separate lines of therapy) or in the opinion of the Investigator have been considered ineligible for a particular form of standard of care therapy on medical grounds.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Life expectancy of ≥12 weeks.
  • Have adequate organ function as indicated by the laboratory values listed within the protocol.
  • 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 who have sexual relations with WOCBP 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.
  • Able to provide tumor tissue sample (archival or newly obtained core or excisional biopsy). For Part 1: At biomarker-screening (for NSCLC) or screening (for non-NSCLC) visit of a tumor lesion not previously irradiated for CDH6 testing.
  • For Part 2: Willing to undergo fresh tumor biopsy at biomarker-screening visit (for NSCLC) and screening visit (non-NSCLC) from a lesion that can be biopsied at an acceptable clinical risk as judged by the investigator.

Who cannot join

  • 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%).
  • 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.
  • 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.
  • 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.
  • History of bowel obstruction within 3 months prior to the first dose of study treatment.
  • Known psychiatric disorder or drug abuse that would interfere the study requirements.
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  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment.
  • Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment.
  • History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease.
  • Prior exposure to other CDH6-targeted agents.
  • Prior exposure to an ADC with a topoisomerase I inhibitor payload (e.g., raludotatug deruxtecan/DS-6000) for all cohorts except for the topoisomerase inhibitor payload ADC-pretreated participants in PROC cohort.
  • Has not recovered (i.e., to CTCAE version 5.0 Grade 1 or to baseline) from previous anticancer therapy-induced AEs. Grade ≤2 AEs with no impact on participant safety are exceptions to this criterion and may qualify for the study.
  • Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of SIM0505.
  • Major surgery within 2 weeks of receiving the first dose of study treatment.
  • Has received prior anti-cancer therapies within the following time frames prior to the first dose of study treatment: previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors), hormonal agents within 2 weeks; anti-cancer antibody or ADC within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study treatment; Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks; and/or radiation therapy within 2 weeks for focal radiation or within 4 weeks for wide-field radiation.
  • Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.
  • Administration of strong or moderate CYP3A4 inhibitors or drugs with known risk of Torsades de Pointes (TdP) ≤ 7 days or 3 half-lives (whichever is longer) prior to the first dose of SIM0505.
  • Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
  • Active hepatitis B or hepatitis C infection.
  • Participants with clinically significant cardiovascular diseases.
  • History of allogeneic organ transplantation or graft-versus-host disease.
  • Known hypersensitivity to study drug or any of the excipients.
  • Participant is pregnant or breastfeeding.
  • Other conditions that researchers consider inappropriate for inclusion.

Trial locations and contacts

17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Udayan Guha, PhD, MD contact

301-919-4218

NCClin@nextcure.com

Siyuan Qian contact

Siyuan.Qian@zaiming.com

17 sites in 2 countries

United States9 sites

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

    Active, not recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Active, not recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Active, not recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Active, not recruiting

  • Sarah Cannon Research Institute (SCRI) - Nashville

    Nashville, Tennessee, 37203

    Active, not recruiting

  • University Medical Center of New Orleans LSU-LCMC Health Cancer Center

    New Orleans, Louisiana, 70112

    Active, not recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10128

    Active, not recruiting

  • Sarah Cannon Research Institute (SCRI) - Lake Nona

    Orlando, Florida, 32827

    Active, not recruiting

  • UT Health San Antonio - Mays Cancer Center

    San Antonio, Texas, 78229

    Active, not recruiting

Other trials in United States

China8 sites, 8 recruiting

  • The first medical center of PLA general hospital

    Beijing, Beijing Municipality, 100000

    Yi Hu, Ph D

    Recruiting

  • HunanCancer Hospital

    Changsha, Hunan, 430100

    Dihong Tang

    Shusuan Jiang

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Jundong Li

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Yan Zhang

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

    Xiaowei Liu

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xiaohua Wu, Ph D

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, China, 110092

    Hongxu Liu

    Not yet recruiting

  • The Fourth Hospital of Hebei Medical University (Heibei Tumor Hospital)

    Shijiazhuang, China, 050010

    Ziqiang Tian

    Mingxia Wang

    Not yet recruiting

Other trials in China

About this study

Official title: A 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

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

Being tested
SIM0505 for injection
Medical subject headings
Fallopian Tube Neoplasms, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIM0505 for injectionDrug

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

  • SIM0505 for injectionDrug

    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

Study groups in NCT06792552
Study groupRoleWhat they receive
SIM0505 mono dose escalationExperimentalEvery 21 days is one cycle. Multiple dose levels of SIM0505 will be explored in dose escalation, and determine the maximum tolerated dose.
Receives: Drug: SIM0505 for injection
SIM0505 mono dose optimization - PROCExperimentalEvery 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 PROC.
Receives: Drug: SIM0505 for injection
SIM0505 mono dose optimization - RCCExperimentalEvery 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 RCC.
Receives: Drug: SIM0505 for injection
SIM0505 mono dose optimization - USCExperimentalEvery 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 USC.
Receives: Drug: SIM0505 for injection
SIM0505 mono dose optimization - NSCLCExperimentalEvery 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 NSCLC.
Receives: Drug: SIM0505 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. dose escalation: Dose-limiting toxicity (DLT)

    Measured: At the end of Cycle 1 (each cycle is 21 days)

  2. dose escalation & optimization: Adverse events (AEs)

    Measured: the whole dose escalation phase，an average of 2 year

  3. dose optimization：Objective response rate (ORR)

    Measured: the whole dose optimization phase，an average of 1.5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study start26 Feb 2025
  3. Primary completionFeb 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
738 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06792552
Sponsor's protocol ID
SIM0505-101
Status last verified
Jul 2026
First submitted
13 Jan 2025
Last updated
17 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SIM0505 for injection in people with Advanced Solid Tumors and Platinum Resistant Ovarian Cancer, run by NextCure, Inc. at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Udayan Guha, PhD, MD (301-919-4218, NCClin@nextcure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dose escalation: Dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06792552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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