Advanced Solid TumorsPhase 2NCT07046650
Multi-cohort, Single-arm, Phase II Study of the Efficacy and Side Effects of Cisplatin Plus Gemcitabine in the Treatment of PD1 Failure or Intensive Treatment of Some Rare Tumors
A Phase 2 study testing cisplatin-based chemotherapy in people with Advanced Solid Tumors, run by Sheng Zhang at 1 site in China.
Trial summary
This is a multi-cohort, single-arm, phase II study of the efficacy and side effects of cisplatin plus gemcitabine in the treatment of PD1 failure or intensive treatment of some rare tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- cisplatin-based chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Jul 2028
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Written informed consent was obtained before enrollment. 2. Age ≥18 years old; 3. Patients with corresponding cancer confirmed by histological and/or cytological examination; 4. Consent to treatment; 5. ECOG score: 0-1; 6. Previous PD-1 therapy failure; 7. At least one measurable lesion (≥10 mm on CT scan for non-nodal lesions and ≥15 mm on CT scan for nodal lesions according to RECIST criteria).
- 8. Have adequate organ function: 9. Blood routine: Absolute Neutrophil Count (ANC) 1.5×109/L, Platelet (PLT) ≥70×109/L, Hemoglobin (HGB) ≥80g/L; 10. Liver function: serum Total Bilirubin (TBIL) ≤1.5× Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3×ULN; Serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; Patients who met the above criteria after conventional liver-protective therapy and could be stable for at least 1 week could be enrolled after investigator's evaluation.
- 11. Renal function: creatinine clearance ≥60 mL/mi (using the standard Cockcroft-Gault formula) : 12. Coagulation: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN; If the subject is receiving anticoagulant therapy, as long as the PT and INR are within the prescribed range of anticoagulant drugs 13. Estimated survival time ≥3 months; 14. Contraception during treatment 15. Ability to adhere to study access schedules and other protocol requirements.
Who cannot join
- 1. Poor patient compliance; 2. Prior exposure to cisplatin and/or gemcitabine and documented progression 3. With ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥ grade 2 congestive heart failure (New York Heart Association [NYHA] classification); 4. Severe active or uncontrolled infection (≥CTCAE grade 2 infection) requiring systemic antibacterial, antifungal, or antiviral therapy, including pulmonary tuberculosis infection.
- 5. Active hepatitis (transaminase did not meet the inclusion criteria, hepatitis B reference: HBV DNA≥2000 IU/ml or ≥104 copies /ml; Hepatitis C reference: HCV RNA≥2000 IU/ml or ≥104 copies /ml; After nucleotide antiviral therapy, those below the above criteria can be enrolled). Chronic hepatitis B virus carriers with HBV DNA < 104 IU/ml could only be enrolled if they received antiviral therapy at the same time during the trial.
- 6. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7. Severe nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness and constipation; 8. Patients with a history of active tuberculosis; 9. Patients who underwent major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the initiation of study treatment; Or have a wound or fracture that has not healed for a long time; 10. Currently participating or having participated in another clinical investigator within 4 weeks before study initiation 11. Patients with a history of severe allergies 12. Is at risk for bleeding, or has coagulopathy, or is receiving thrombolytic therapy 13. People who have a history of psychotropic drug abuse and cannot quit or have mental disorders 14. Subjects who, in the investigator's judgment, had a concomitant medical condition that seriously compromised the safety of the subjects or interfered with the completion of the study, or who were deemed to be ineligible for enrollment for any other reason. "There was a clear previous history of neurological and psychiatric disorders, such as dementia, epilepsy, or seizure prone episodes.
- 15. The presence of concomitant diseases (such as severe diabetes mellitus, thyroid disease, and psychosis), or serious and/or unstable medical, psychiatric, or other conditions (including laboratory abnormalities) that, in the judgment of the investigators, seriously compromise the safety of the subjects or prevent the subjects from completing the study, or the presence of serious and/or unstable medical, psychiatric, or other conditions (including laboratory abnormalities) that affect the safety of the patients or prevent the patients from providing informed consent, "Or the presence of any psychological, family, sociological, or geographic factors that affect the study protocol and follow-up plan.
- 16. The investigator did not consider it appropriate to participate in the trial for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Cancer Center, Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
This is a multi-cohort, single-arm, phase II study of the efficacy and side effects of cisplatin plus gemcitabine in the treatment of PD1 failure or intensive treatment of some rare tumors
Read the detailed description
- cisplatin plus gemcitabine regimen; Cisplatin-based chemotherapy, which is widely used in clinical oncology, is the cornerstone of many cancer treatments. Among them, it is extremely critical and important for germ cell tumors, especially testicular cancer, and for advanced urothelial cancer. In all treatment guidelines, cisplatin-based chemotherapy is used for advanced urothelial cancer. Cisplatin is also the most important drug in the treatment of testicular cancer, and it is an independent prognostic factor for the long-term survival of patients. The rapid development of immunotherapy, especially PD1, has made PD1 enter the front line of cancer treatment. It has become a first-line treatment typically for advanced urothelial cancer. "Advanced adrenocortical carcinoma, pheochromocytoma, extramammary PAGET's disease of the scrotum, advanced urachal carcinoma, and urinary sarcoma (after treatment with doxorubicin) are rare diseases for which standard treatment is lacking." However, PD1 is recommended by various guidelines due to its better safety. So, in the era of rapid changes in new treatment modalities, that is, after PD1 has entered the standard of care, does cisplatin-based chemotherapy still have corresponding anti-tumor activity?
- treatment status of advanced bladder urothelial carcinoma Advanced bladder urothelial carcinoma (UC) is a highly fatal disease, and its treatment methods are diverse, but the effect is often limited by the metastatic site of the patient's tumor. In recent years, the rise of immunotherapy and ADC therapy has brought new hope to UC patients.
ADC drugs are a new direction in the field of urothelial cancer. A number of ADC drugs are available at home and abroad, including Enfortumab Vedotin (EV) 1, Sacituzumab Govitecan, and enfortumab vedotin. SG) and Disitamab Vedotin (RC48) have shown good efficacy in patients with advanced urothelial carcinoma after conventional treatment failure, and have become the treatment recommendation of guidelines and routine choice in clinical practice at home and abroad. ADC drug therapy may induce immunogenic cell death (ICD), thereby producing a synergistic anti-tumor effect with immunotherapy and further improving the efficacy. RC48 plus toripalimab: RC48-C014, a phase 1b/II study evaluating the efficacy and safety of RC48 plus toripalimab in patients with metastatic urothelial cancer, was updated at this meeting. A total of 32 patients were enrolled in the study, of which 28% had liver metastases, 62.5% had HER2 IHC(2+/3+), 37.5% had HER2 IHC(0/1+), and 56% had CPS≥1. In 20 patients with at least two responses, the confirmed ORR was 75% (95% CI, 50.9 to 91.3), with a CR rate of 15% and a DCR rate of 95% (95% CI, 75.1 to 99.9).
However, with the rapid change of treatment mode, the combination of ADC and PD1 has been confirmed in the EV3023,4 study, and the efficacy is much better than that of the traditional platinum-based first-line chemotherapy. This finding has led to a shift in the treatment of advanced urothelial carcinoai5 to first-line combination therapy with PD1 and EV, regardless of FDA approval or guidelines such as the NCCN.
In this context, first-line PD1 plus ADC therapy has become a game-changing new paradigm. However, the treatment of these patients after progression is still under controversy, and there is no relevant clinical research results to guide clinical practice.
A substantial number of patients in China choose these treatment modalities either as a result of enrollment in these clinical trials or on their own. A significant number of patients received first-line treatment with PD1 and ADC. However, since the active ingredient of vedicitumumab is anti-microtubule MMAE. Does the initial use of the drug affect the efficacy of subsequent platinum therapy? However, the toxicity of MMAE was mainly neurotoxicity. Platinum also has some neurotoxicity. So the toxicity effect on subsequent platinum therapy? Based on this, we designed the efficacy and safety of cisplatin combined with gemcitabine in patients with advanced urothelial carcinoma who had failed PD-1 and vedicitumumab treatment (arm 1). The efficacy of cisplatin plus gemcitabine was tested in individual rare cancers (arm II to arm IV).
- Objectives of the study To determine the efficacy and safety of cisplatin combined with gemcitabine in some patients with pelvic tumors after standard treatment and PD1 failure.
- Conditions
- Advanced Solid Tumors
- Being tested
- cisplatin-based chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin-based chemotherapyCombination product
Patients were required to have a creatinine clearance of more than 60 and to receive standard doses of cisplatin and gemcitabine (gemcitabine 1000mg /m2 on day 1.8 and cisplatin 70 mg /m2 on day 1, q3w). A total of 4-6 courses of treatment were performed.
| Study group | Role | What they receive |
|---|---|---|
| Rare Tumor 2 | Experimental | Patients with extramammary PAGET's disease, after PD1 failure. Receives: Combination Product: cisplatin-based chemotherapy |
| Rare Tumor 3 | Experimental | Patients with advanced adrenocortical carcinoma, following PD1 failure. Receives: Combination Product: cisplatin-based chemotherapy |
| Rare Tumor 4 | Experimental | Patients with advanced urachal cancer, after PD1 failure. Receives: Combination Product: cisplatin-based chemotherapy |
| Arm 1 | No intervention | Patients with advanced urothelial cancer in whom PD-1 and vedicitumumab had failed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The sum of the proportion of subjects with Complete response or Partial response
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Incidence of adverse events (AE)
Incidence of adverse events (AE)
Measured: through study completion, an average of 2 years
During of response
The time between the start of the first assessment of the tumor as Complete response or Partial response and the second assessment as PD(Progressive Disease) or death from any cause
Measured: through study completion, an average of 1 year
Progression Free Survival
The time, measured in days, from the date of first treatment to disease progression or death from any cause. Disease progression and death were measured in terms of preoccurrence. Progression included radiographic progression or clinical progression as assessed by the investigator.
Measured: through study completion, an average of 1 year
Overall Survival
The time from the date of first treatment to death from any cause, measured in days
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jan 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheng Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046650
- Sponsor's protocol ID
- 2501313
- Status last verified
- Jan 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-cohort, Single-arm, Phase II Study of the Efficacy and Side Effects of Cisplatin Plus Gemcitabine in the Treatment of PD1 Failure or Intensive Treatment of Some Rare Tumors
- ClinicalTrials.gov ID
- NCT07046650
- Acronym / sponsor ID
- 2501313
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sheng ZhangUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-cohort, single-arm, phase II study of the efficacy and side effects of cisplatin plus gemcitabine in the treatment of PD1 failure or intensive treatment of some rare tumors
Detailed description
- cisplatin plus gemcitabine regimen; Cisplatin-based chemotherapy, which is widely used in clinical oncology, is the cornerstone of many cancer treatments. Among them, it is extremely critical and important for germ cell tumors, especially testicular cancer, and for advanced urothelial cancer. In all treatment guidelines, cisplatin-based chemotherapy is used for advanced urothelial cancer. Cisplatin is also the most important drug in the treatment of testicular cancer, and it is an independent prognostic factor for the long-term survival of patients. The rapid development of immunotherapy, especially PD1, has made PD1 enter the front line of cancer treatment. It has become a first-line treatment typically for advanced urothelial cancer. "Advanced adrenocortical carcinoma, pheochromocytoma, extramammary PAGET's disease of the scrotum, advanced urachal carcinoma, and urinary sarcoma (after treatment with doxorubicin) are rare diseases for which standard treatment is lacking." However, PD1 is recommended by various guidelines due to its better safety. So, in the era of rapid changes in new treatment modalities, that is, after PD1 has entered the standard of care, does cisplatin-based chemotherapy still have corresponding anti-tumor activity?
- treatment status of advanced bladder urothelial carcinoma Advanced bladder urothelial carcinoma (UC) is a highly fatal disease, and its treatment methods are diverse, but the effect is often limited by the metastatic site of the patient's tumor. In recent years, the rise of immunotherapy and ADC therapy has brought new hope to UC patients.
ADC drugs are a new direction in the field of urothelial cancer. A number of ADC drugs are available at home and abroad, including Enfortumab Vedotin (EV) 1, Sacituzumab Govitecan, and enfortumab vedotin. SG) and Disitamab Vedotin (RC48) have shown good efficacy in patients with advanced urothelial carcinoma after conventional treatment failure, and have become the treatment recommendation of guidelines and routine choice in clinical practice at home and abroad. ADC drug therapy may induce immunogenic cell death (ICD), thereby producing a synergistic anti-tumor effect with immunotherapy and further improving the efficacy. RC48 plus toripalimab: RC48-C014, a phase 1b/II study evaluating the efficacy and safety of RC48 plus toripalimab in patients with metastatic urothelial cancer, was updated at this meeting. A total of 32 patients were enrolled in the study, of which 28% had liver metastases, 62.5% had HER2 IHC(2+/3+), 37.5% had HER2 IHC(0/1+), and 56% had CPS≥1. In 20 patients with at least two responses, the confirmed ORR was 75% (95% CI, 50.9 to 91.3), with a CR rate of 15% and a DCR rate of 95% (95% CI, 75.1 to 99.9).
However, with the rapid change of treatment mode, the combination of ADC and PD1 has been confirmed in the EV3023,4 study, and the efficacy is much better than that of the traditional platinum-based first-line chemotherapy. This finding has led to a shift in the treatment of advanced urothelial carcinoai5 to first-line combination therapy with PD1 and EV, regardless of FDA approval or guidelines such as the NCCN.
In this context, first-line PD1 plus ADC therapy has become a game-changing new paradigm. However, the treatment of these patients after progression is still under controversy, and there is no relevant clinical research results to guide clinical practice.
A substantial number of patients in China choose these treatment modalities either as a result of enrollment in these clinical trials or on their own. A significant number of patients received first-line treatment with PD1 and ADC. However, since the active ingredient of vedicitumumab is anti-microtubule MMAE. Does the initial use of the drug affect the efficacy of subsequent platinum therapy? However, the toxicity of MMAE was mainly neurotoxicity. Platinum also has some neurotoxicity. So the toxicity effect on subsequent platinum therapy? Based on this, we designed the efficacy and safety of cisplatin combined with gemcitabine in patients with advanced urothelial carcinoma who had failed PD-1 and vedicitumumab treatment (arm 1). The efficacy of cisplatin plus gemcitabine was tested in individual rare cancers (arm II to arm IV).
- Objectives of the study To determine the efficacy and safety of cisplatin combined with gemcitabine in some patients with pelvic tumors after standard treatment and PD1 failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rare Tumor 2 | Experimental | Combination Product: cisplatin-based chemotherapyPatients with extramammary PAGET's disease, after PD1 failure. |
| Rare Tumor 3 | Experimental | Combination Product: cisplatin-based chemotherapyPatients with advanced adrenocortical carcinoma, following PD1 failure. |
| Rare Tumor 4 | Experimental | Combination Product: cisplatin-based chemotherapyPatients with advanced urachal cancer, after PD1 failure. |
| Arm 1 | No intervention | –Patients with advanced urothelial cancer in whom PD-1 and vedicitumumab had failed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Written informed consent was obtained before enrollment. 2. Age ≥18 years old; 3. Patients with corresponding cancer confirmed by histological and/or cytological examination; 4. Consent to treatment; 5. ECOG score: 0-1; 6. Previous PD-1 therapy failure; 7. At least one measurable lesion (≥10 mm on CT scan for non-nodal lesions and ≥15 mm on CT scan for nodal lesions according to RECIST criteria).
- 8. Have adequate organ function: 9. Blood routine: Absolute Neutrophil Count (ANC) 1.5×109/L, Platelet (PLT) ≥70×109/L, Hemoglobin (HGB) ≥80g/L; 10. Liver function: serum Total Bilirubin (TBIL) ≤1.5× Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3×ULN; Serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; Patients who met the above criteria after conventional liver-protective therapy and could be stable for at least 1 week could be enrolled after investigator's evaluation.
- 11. Renal function: creatinine clearance ≥60 mL/mi (using the standard Cockcroft-Gault formula) : 12. Coagulation: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN; If the subject is receiving anticoagulant therapy, as long as the PT and INR are within the prescribed range of anticoagulant drugs 13. Estimated survival time ≥3 months; 14. Contraception during treatment 15. Ability to adhere to study access schedules and other protocol requirements.
Key exclusion criteria (5 listed)
- 1. Poor patient compliance; 2. Prior exposure to cisplatin and/or gemcitabine and documented progression 3. With ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥ grade 2 congestive heart failure (New York Heart Association [NYHA] classification); 4. Severe active or uncontrolled infection (≥CTCAE grade 2 infection) requiring systemic antibacterial, antifungal, or antiviral therapy, including pulmonary tuberculosis infection.
- 5. Active hepatitis (transaminase did not meet the inclusion criteria, hepatitis B reference: HBV DNA≥2000 IU/ml or ≥104 copies /ml; Hepatitis C reference: HCV RNA≥2000 IU/ml or ≥104 copies /ml; After nucleotide antiviral therapy, those below the above criteria can be enrolled). Chronic hepatitis B virus carriers with HBV DNA < 104 IU/ml could only be enrolled if they received antiviral therapy at the same time during the trial.
- 6. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7. Severe nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness and constipation; 8. Patients with a history of active tuberculosis; 9. Patients who underwent major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the initiation of study treatment; Or have a wound or fracture that has not healed for a long time; 10. Currently participating or having participated in another clinical investigator within 4 weeks before study initiation 11. Patients with a history of severe allergies 12. Is at risk for bleeding, or has coagulopathy, or is receiving thrombolytic therapy 13. People who have a history of psychotropic drug abuse and cannot quit or have mental disorders 14. Subjects who, in the investigator's judgment, had a concomitant medical condition that seriously compromised the safety of the subjects or interfered with the completion of the study, or who were deemed to be ineligible for enrollment for any other reason. "There was a clear previous history of neurological and psychiatric disorders, such as dementia, epilepsy, or seizure prone episodes.
- 15. The presence of concomitant diseases (such as severe diabetes mellitus, thyroid disease, and psychosis), or serious and/or unstable medical, psychiatric, or other conditions (including laboratory abnormalities) that, in the judgment of the investigators, seriously compromise the safety of the subjects or prevent the subjects from completing the study, or the presence of serious and/or unstable medical, psychiatric, or other conditions (including laboratory abnormalities) that affect the safety of the patients or prevent the patients from providing informed consent, "Or the presence of any psychological, family, sociological, or geographic factors that affect the study protocol and follow-up plan.
- 16. The investigator did not consider it appropriate to participate in the trial for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin-based chemotherapyPatients were required to have a creatinine clearance of more than 60 and to receive standard doses of cisplatin and gemcitabine (gemcitabine 1000mg /m2 on day 1.8 and cisplatin 70 mg /m2 on day 1, q3w). A total of 4-6 courses of treatment were performed. | Combination product | Rare Tumor 2, Rare Tumor 3, Rare Tumor 4 |
Primary outcome
Objective Response Rate
Time frame: through study completion, an average of 1 year
The sum of the proportion of subjects with Complete response or Partial response
4 secondary outcomes
Incidence of adverse events (AE)
Time frame: through study completion, an average of 2 years
During of response
Time frame: through study completion, an average of 1 year
Progression Free Survival
Time frame: through study completion, an average of 1 year
Overall Survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin-based chemotherapy in people with Advanced Solid Tumors, run by Sheng Zhang at 1 site in China.
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 3 inclusion and 5 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sheng Zhang, PhD (86+18017317442, 568841700@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2025.