Malignant Solid TumorsPhase 1NCT05441046
Genakumab Alone and in Combination With Tislelizumab in Patients With Advanced Malignant Solid Tumors
A Phase 1 study testing Genakumab in people with Malignant Solid Tumors, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a phase I, multicenter, open-label dose escalation and expansion study to evaluate genakumab alone and in combination with tislelizumab in adult patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Solid Tumors
- What is being tested?
- Genakumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2022to Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients may be enrolled in the study only if they meet all of the following inclusion criteria:
- Patients with advanced malignant tumors by histopathological diagnosis who do not have any acceptable standard treatments currently. Tumor types are specified as follows:
- Part I (Dose escalation): malignant solid tumors.
- Part II (Dose expansion):
- Cohort A: malignant solid tumors (excluding colorectal cancer and pancreatic cancer).
- Cohort B: colorectal cancer. Cohort C: pancreatic cancer.
Show all 18Show fewer
- Patients who have provided informed consent prior to initiation of any study-specific activities/procedures.
- Age 18-75 years old.
- Life expectancy ≥ 12 weeks.
- Solid tumor with ≥ 1 measurable lesion that can be used to measure response according to RECIST v1.1. Index lesions must not be chosen from previously irradiated field unless there has been demonstrated disease progression in that lesion.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate organ function defined as follow:
- Hematological (without need for hematopoietic growth factor or transfusion support within 14 days prior to screening) Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count (PLT) ≥ 75 x 109/L Hemoglobin (HGB) ≥ 90 g/L
- Hepatic Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR ≤ 3 x ULN for patients with liver metastases or Gilbert syndrome Aspartate aminotransferase (AST) ≤ 2.5 x ULN OR ≤ 5 x ULN for patients with liver metastases Alanine aminotransferase (ALT) ≤ 2.5 x ULN OR ≤ 5 x ULN for patients with liver metastases
- Renal Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 45 mL/min (according to the Cockcroft-Gault equation)
- Coagulation Activated thromboplastin time (aPTT) ≤ 1.5 x ULN International normalization ratio (INR) ≤ 1.5 x ULN If the patient is receiving anticoagulant therapy, the aPTT or INR must be in the therapeutic range of intended use of anticoagulants.
- Female patients with the possibility of pregnancy: Agree to practice sexual abstinence or use effective methods of contraception from the time of signing the ICF until at least 6 months after the end of dosing. Male patients: Agree to practice abstinence or use effective contraception from the time of signing the ICF until at least 6 months after the end of dosing.
- Patients who have recovered from the toxic effects of the last treatment (CTCAE ≤ grade 1, except for special circumstances such as "alopecia") before the first dosing.
Who cannot join
- Patients with any of the following conditions may not be enrolled in the study:
- Prior treatment with IL-1β-targeting agents.
- Patients with previous severe allergic reactions to any investigational drugs or its components in this trial.
- Previous or current other types of malignancy diagnosed within 3 years, except as follows: basal cell or squamous cell skin cancer that has been cured, any type of carcinoma in situ that has been cured.
- Symptomatic central nervous system metastases. Patients with asymptomatic CNS metastases or patients who are radiologically and neurologically stable ≥ 2 weeks following CNS-directed therapy are eligible.
- Patients who have received any of the following treatments within 4 weeks or within 5 half-lives prior to the first dosing (whichever is shorter):
Show all 28Show fewer
- Anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, tumor artery embolization, and radiotherapy, excluding palliative radiotherapy);
- Any biological agents targeting immune system (e.g., TNF blockers, anakinra, rituximab, abatacept or tocilizumab, etc);
- Any live vaccines or live attenuated vaccines;
- Any other investigational drugs or another interventional clinical study (except for the following: patients who participate in an observational, non-interventional clinical study, or are in the follow-up period of an interventional clinical study).
- Major surgery or severe trauma within 4 weeks prior to the first dosing. Wounds and injuries must be fully recovered. Note: Video-assisted thoracoscopic surgery (VATS) and mediastinoscopy are not considered as major surgery. Patients who have received VATS or mediastinoscopy more than 2 weeks prior to the first dosing may be enrolled at the discretion of the investigator.
- Patients who have a cardiovascular clinical condition or symptom including:
- Unstable angina or myocardial infarction in the past 6 months;
- Coronary artery bypass grafting (CABG) in the past 6 months;
- Congestive heart failure (NYHA class 2);
- Clinically significant malignant arrhythmia (e.g., persistent ventricular tachycardia, clinically significant second- or third-degree atrioventricular block without a pacemaker).
- Uncontrolled diabetes or hypertension defined by the investigator.
- History of interstitial lung disease.
- Active or recurrent liver disease, including hepatitis B, hepatitis C, and liver cirrhosis.
- Patients with active pulmonary tuberculosis found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection before enrollment (Patients who have received anti-tuberculosis treatment and further examinations confirm that there is no evidence of active infection are eligible.).
- Patients with active infection requiring systematic treatment within 2 weeks prior to the first dosing (Patients with skin infection requiring only topical treatment are eligible.).
- Patients with suspected or proven immunocompromised state, including:
- Patients with evidence of Human Immunodeficiency Virus (HIV) infection;
- Patients requiring systemic or local treatment with any immune modulating agent in doses with systemic effects e.g., high dose oral or intravenous steroids (> 10 mg/d prednisone or its equivalents) or high dose methotrexate (> 15 mg weekly). Topical, inhaled, local steroid use in doses that are not considered to cause systemic effects are permitted.
- Patients with active or recurrent autoimmune disease, excluding: hypothyroidism with replacement therapy, skin disease without need for systemic treatment;
- Patients with history of allogenic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation);
- Patients with any other medical condition which in the opinion of the investigator places the patients at unacceptable risk for participation in immunomodulatory therapy.
- Female patients who are pregnant or lactating, or have a positive pregnancy test result at baseline.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiangdong Cheng, 86 13968032995, chengxd516@126.com
Tao Zhang
About this study
Official title: Phase I and Extended Clinical Study of Safety, Tolerability, and Pharmacokinetics of Injectable Genakumab Alone and Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors
This is a phase I, multicenter, open-label dose escalation and expansion study to evaluate genakumab alone and in combination with tislelizumab in adult patients with advanced solid malignancies.
Read the detailed description
The study is divided into two parts:
Part I:
Part Ia: Two dose groups are planned, which are genakumab 200 mg, 300 mg. Genakumab is administered subcutaneously once every three weeks.
Part Ib: Three dose groups are planned, which are genakumab 100 mg plus tislelizumab 200 mg, genakumab 200 mg plus tislelizumab 200 mg, genakumab 300 mg plus tislelizumab 200 mg. Genakumab is administered subcutaneously once every three weeks. Tislelizumab is administered intravenously following genakumab on D1 of every cycle.
The study process of Part I includes the screening period (4 weeks), the observation period of dose-limiting toxicity (DLT) evaluation (defined as 3 weeks after first dosing), continuous dosing period (dosing once every 3 weeks until the discontinuation criteria are met), safety follow-up period after discontinuation (28±5 days after last dosing) and progression-free survival follow-up period after discontinuation (once every 6 weeks, until the progression-free survival follow-up endpoint).
Part II:
The sponsor and the investigator will choose one dose level as RP2D based on the totality of safety, PK, PD, and preliminary efficacy data from Part I. Additional 90 patients (30 patients for each cohort) will be treated at this dose level. The administration method is the same as that in Part I while without DLT observation.
- Conditions
- Malignant Solid Tumors
- Being tested
- Genakumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenakumabDrug
Also called Tislelizumab
genakumab plus tislelizumab 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Genakumab | Experimental | genakumab plus tislelizumab 200 mg Receives: Drug: Genakumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxicities (DLTs)
Measured: First cycle (21 days after first dose)
adverse events (AEs) adverse events (AEs)
Measured: through study completion, an average of 6 months
serious adverse events (SAEs)
Measured: through study completion, an average of 6 months
PK parameters of genakumab: bioavailability
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: peak concentration (Cmax)
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: area under time-concentration curve (AUC)
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: t1/2
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: steady-state peak concentration
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: steady-state trough concentration
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: accumulation ratio
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Secondary outcomes (6)
Pharmacodynamic: hsCRP
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: total IL-1β
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: free IL-1β
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: IL-6
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: IL-8
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: TNF-α.
Measured: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start7 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorsStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiangdong Cheng, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441046
- Sponsor's protocol ID
- Gensci048-ST-I
- Status last verified
- May 2022
- First submitted
- 16 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I and Extended Clinical Study of Safety, Tolerability, and Pharmacokinetics of Injectable Genakumab Alone and Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05441046
- Acronym / sponsor ID
- Gensci048-ST-I
- Conditions
- Malignant Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 1 Jul 2022 (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 phase I, multicenter, open-label dose escalation and expansion study to evaluate genakumab alone and in combination with tislelizumab in adult patients with advanced solid malignancies.
Detailed description
The study is divided into two parts:
Part I:
Part Ia: Two dose groups are planned, which are genakumab 200 mg, 300 mg. Genakumab is administered subcutaneously once every three weeks.
Part Ib: Three dose groups are planned, which are genakumab 100 mg plus tislelizumab 200 mg, genakumab 200 mg plus tislelizumab 200 mg, genakumab 300 mg plus tislelizumab 200 mg. Genakumab is administered subcutaneously once every three weeks. Tislelizumab is administered intravenously following genakumab on D1 of every cycle.
The study process of Part I includes the screening period (4 weeks), the observation period of dose-limiting toxicity (DLT) evaluation (defined as 3 weeks after first dosing), continuous dosing period (dosing once every 3 weeks until the discontinuation criteria are met), safety follow-up period after discontinuation (28±5 days after last dosing) and progression-free survival follow-up period after discontinuation (once every 6 weeks, until the progression-free survival follow-up endpoint).
Part II:
The sponsor and the investigator will choose one dose level as RP2D based on the totality of safety, PK, PD, and preliminary efficacy data from Part I. Additional 90 patients (30 patients for each cohort) will be treated at this dose level. The administration method is the same as that in Part I while without DLT observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genakumab | Experimental | Drug: Genakumabgenakumab plus tislelizumab 200 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients may be enrolled in the study only if they meet all of the following inclusion criteria:
- Patients with advanced malignant tumors by histopathological diagnosis who do not have any acceptable standard treatments currently. Tumor types are specified as follows:
- Part I (Dose escalation): malignant solid tumors.
- Cohort A: malignant solid tumors (excluding colorectal cancer and pancreatic cancer).
- Cohort B: colorectal cancer. Cohort C: pancreatic cancer.
Key exclusion criteria (28 listed)
- Prior treatment with IL-1β-targeting agents.
- Patients with previous severe allergic reactions to any investigational drugs or its components in this trial.
- Previous or current other types of malignancy diagnosed within 3 years, except as follows: basal cell or squamous cell skin cancer that has been cured, any type of carcinoma in situ that has been cured.
- Symptomatic central nervous system metastases. Patients with asymptomatic CNS metastases or patients who are radiologically and neurologically stable ≥ 2 weeks following CNS-directed therapy are eligible.
- Patients who have received any of the following treatments within 4 weeks or within 5 half-lives prior to the first dosing (whichever is shorter):
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 |
|---|---|---|
| GenakumabAlso: Tislelizumabgenakumab plus tislelizumab 200 mg | Drug | Genakumab |
Primary outcome
dose-limiting toxicities (DLTs)
Time frame: First cycle (21 days after first dose)
adverse events (AEs) adverse events (AEs)
Time frame: through study completion, an average of 6 months
serious adverse events (SAEs)
Time frame: through study completion, an average of 6 months
PK parameters of genakumab: bioavailability
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: peak concentration (Cmax)
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: area under time-concentration curve (AUC)
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: t1/2
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: steady-state peak concentration
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: steady-state trough concentration
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
PK parameters of genakumab: accumulation ratio
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
6 secondary outcomes
Pharmacodynamic: hsCRP
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: total IL-1β
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: free IL-1β
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: IL-6
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: IL-8
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Pharmacodynamic: TNF-α.
Time frame: Cycle 1 day 1/day 2/day 3/day 4/day 6/day 8/day 15, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1/day 2/day 3/day 4/day 6/day 8/day 15, and day 1 of every following cycles (every cycle is 21 days) through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Related trials for Malignant Solid Tumors
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
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
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical 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. This study is not recruiting at the moment.
Xiangdong Cheng principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Genakumab in people with Malignant Solid Tumors, run by Changchun GeneScience Pharmaceutical Co., Ltd. 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 18 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuaishuai Zhang, MD (86 21 6087 1690, zhangshuaishuai@gensci-china.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limiting toxicities (DLTs) (time frame: First cycle (21 days after first dose)). The study lists 10 primary outcomes in all. 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 6 Jul 2022.