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Tests treatment safety and results for Solid Tumors
Official title A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors
ClinicalTrials.gov ID: NCT07105215
What this study is testing
What is RC278?
RC278 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumors.
Also referred to as RC278 For Injection.
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
- The primary objective is to evaluate the safety and tolerability of RC278; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC278; and determine the recommended phase 2 dose (RP2D)， and assess the efficacy of RC278 at the RP2D dose;
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;
- Age between 18 and 75 years (including 18 and 75 years);
- ECOG PS score of 0 or 1;
- Expected survival ≥12 weeks;
- According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
You likely can't join if
- Pregnant, breastfeeding, or intending to become pregnant people.
- people with brain metastases.
- people with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade 1.
- people with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
- people with acute, chronic, or symptomatic infections.
- people with uncontrolled cardiovascular diseases.
See the full eligibility criteria
- Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;
- Age between 18 and 75 years (including 18 and 75 years);
- ECOG PS score of 0 or 1;
- Expected survival ≥12 weeks;
- According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
- Sufficient bone marrow, liver, kidney, and blood clotting function
- Pregnant, breastfeeding, or intending to become pregnant people.
- people with brain metastases.
- people with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade 1.
- people with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
- people with acute, chronic, or symptomatic infections.
- people with uncontrolled cardiovascular diseases.
- people with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.
- people with a history of cirrhosis (Child-Pugh B or C class).
- people with active inflammatory bowel disease.
- people with uncontrolled diabetes (HbA1c ≥ 10%).
- people who experienced arterial/venous thromboembolic events, deep vein thrombosis, pulmonary embolism, or stroke within 6 months prior to the first dose.
- people with pericardial effusion or cardiac tamponade, or third-space fluid accumulation, which, in the investigator's judgment, cannot be controlled or stabilized by drainage or other methods.
- people with active autoimmune diseases requiring systemic treatment within the past 2 years.
- people with a history of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from a previously diagnosed malignancy.
- people with a history of other acquired or congenital immunodeficiency diseases or organ transplantation.
- people with a history or current diagnosis of uncontrolled psychiatric disorders.
- people with poor adherence, who are unlikely to comply with the trial procedures.
- people with any other diseases, metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities, which, in the investigator's judgment, raise suspicion of an underlying condition making the...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Guilin, Guangxi, China
- Nanning, Guangxi, China
- Harbin, Heilongjiang, China
- Luoyan, Henan, China
- Luoyang, Henan, China
- Nanyang, Henan, China
- Xinxiang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hu'Nan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
+ 8 more site(s).
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China; Guilin, Guangxi, China; Nanning, Guangxi, China; Harbin, Heilongjiang, China and 22 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.