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New treatment option for Advanced Solid Tumors
Official title A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06792552
What this study is testing
What is SIM0505 for injection?
SIM0505 for injection is an investigational medicine, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- For Part 2: has clear cell, mucinous or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline ovarian cancer; mixed...
- For Part 2: Participants with primary platinum refractory ovarian cancer, defined as disease that did not respond to (CR or PR) or has progressed...
- 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...
- Known untreated CNS metastases and/or leptomeningeal metastases. Participants are eligible if CNS metastases have been treated and participants have...
- 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.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Hackensack, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Beijing, Beijing Municipality, China
- Shenyang, China, China
- Shijiazhuang, China, China
- Guangzhou, Guangdong, China
- Changsha, Hunan, China
- Jinan, Shandong, China
- Jining, Shandong, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Atlanta, Georgia, United States; New Orleans, Louisiana, United States; Boston, Massachusetts, United States; Hackensack, New Jersey, United States; Buffalo, New York, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.