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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...
- 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...
- Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy 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...
See the full eligibility criteria
- 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 adenocarcinoma of NSCLC without actionable mutation of EGFR.
- Presence of CDH6 expression through immunohistochemical examination of tumor tissue. 5\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6\. Life expectancy of ≥12 weeks. 7. Have adequate...
- 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...
- 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...
- Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of...
- 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 or an ADC with a topoisomerase I inhibitor payload (e.g., raludotatug deruxtecan/DS-6000). 12\. Major surgery within 2 weeks of receiving the first dose of study treatment...
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.