Relapsed or Metastatic Thymic CancerPhase 2iTHYMNCT06750952
Ivonescimab Combined with Chemotherapy As First-line Treatment of Relapsed or Metastatic Thymic Cancer: a Prospective, Single Arm, Phase II Trial
A Phase 2 study testing Ivonescimab Combined With Chemotherapy in people with Relapsed or Metastatic Thymic Cancer and First-line Treatment, run by Sun Yat-sen University.
Trial summary
This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Metastatic Thymic Cancer, First-line Treatment
- What is being tested?
- Ivonescimab Combined With Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 20 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated metastatic or recurrent inoperable thymic cancer patients at the initial stage; All patients need to undergo baseline PET/CT (or neck, chest, upper abdominal CT+cranial MR) for clinical staging.
- The patient's age is ≥ 18 years old, with no gender restrictions.
- Pathological diagnosis of thymic carcinoma through cytology/histology.
- Expected survival period ≥ 3 months.
- ECOG (Performance Status, PS) score is 0-1 points.
- Organ function meets:
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- Hematology: I. neutrophils ≥ 1500109/L;II. Platelet ≥ 100109/L; iii、 Hemoglobin >90g/L; Renal function: I. serum creatinine ≤ 1.5ULN or creatinine clearance rate (CrCl) ≥ 50mL/min; II. Urinary protein < 2+ or 24h urinary protein quantitation < 1.0g; Liver function: I, AST or ALT ≤ 3ULN; For patients with liver metastasis, it can be ≤ 5ULN; ii. Total bilirubin ≤ 1.5ULN, liver metastasis patients can be ≤ 3ULN; Iii: serum albumin (ALB) ≥ 28g/L.
- Coagulation function: NR or APTT ≤ 1.5ULN. Cardiac function: left ejection fraction (levf) ≥ 50%. Thyroid function: thyroid stimulating hormone (TSH), free thyroxine (FT4), or free triple Iodothyronine (FT3) was within ± 10% of normal values.
- There were measurable lesions (according to irecist criteria).
- Subjects must understand and voluntarily sign an informed Consent form, and voluntarily comply with other requirements of the study.
- Female subjects with reproductive function must have urine or serum within 3 days before the first medication Pregnancy test (if the urine pregnancy test result cannot be confirmed as negative, serum pregnancy test is required Check, the serum pregnancy results shall prevail). If a female with fertility is different from a male without sterilization The partner had sex, and the subject agreed to continue to use contraception and avoid breastfeeding during the medication period Milk.
- The male subject agreed to continue using contraceptive methods during the medication period.
Who cannot join
- Patients with thymoma component suspected by pathological diagnosis (only thymic cancer patients were enrolled).
- The patient has or is suspected of having autoimmune disease. Note: Patients with vitiligo, type I diabetes, or Hashimoto's thyroiditis who have hypothyroidism but only need hormone replacement therapy can be included in the study when there is no obvious sign of recurrence.
- Patients need to receive systemic cortisol treatment (>10mg prednisolone [or equivalent dose] / day) or use other immunosuppressive drugs within 14 days after enrollment. Note: inhaled or topical corticosteroids, or adrenal hormone replacement therapy (>10mg prednisolone [or equivalent dose] / day) can be accepted for patients without obvious autoimmune disease.
- Patients with grade 3-4 interstitial lung disease.
- At the same time, the patient has other malignant tumors and need anti-tumor treatment.
- Patients with other malignant tumors in the past (excluding skin malignant tumors other than non melanoma, and carcinoma in situ in the following parts [bladder, stomach, colorectal, endometrial, cervical, melanoma or breast]) cannot be included in this study. However, if the malignant tumor has achieved complete remission for five years or more and does not need to receive additional anti-tumor treatment during this study, it can be included in the study.
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- Received live attenuated vaccine within 4 weeks before the first dose or planned during the study.
- Major surgical operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks before the first administration.
- The investigator believes that the patient is medically, psychologically, or physiologically unable to complete the study or understand the information in the patient manual.
- Previously received anti-PD-1, anti-PD-L1, anti-CTLA4, other drugs targeting T cell costimulation or immune regulatory pathways, and anti vascular drugs.
- Myocardial infarction and poorly controlled arrhythmia occurred within 6 months before the first administration (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) (QTc interval was calculated according to fridericia formula); Or according to NYHA criteria for grade III-IV cardiac insufficiency or left ventricular ejection fraction <50% by cardiac color Doppler ultrasound.
- The subject had grade ≥ 2 CTCAE peripheral neuropathy.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. Only a small amount of pleural fluid, ascites and pericardial effusion without clinical symptoms revealed by imaging can be enrolled.
- There are active patients with hepatitis B, C, tuberculosis, syphilis or other serious infections with poor clinical control.
- HIV test positive or have been diagnosed with acquired immune deficiency disease (AIDS).
- Allergic to the study drug or known history of severe allergy to any monoclonal antibody (NCI-CTCAE 5.0 grade > 3).
- Those who received live or attenuated vaccines within 28 days before the first dose or had plans to receive such vaccines during the study; However, inactivated viral vaccines for seasonal influenza are permitted.
- Have a history of severe bleeding tendency or coagulation dysfunction. Those who had deep vein thrombosis, were using anticoagulant or platelet therapy, or had deep vein thrombosis or serious bleeding caused by the use of antiangiogenic drugs in the past 3 months before enrollment; Or any other history of severe thromboembolism (implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism).
- Vascular events occurred in the past 6 months, including cerebrovascular accidents (including transient ischemic attack), any arterial thromboembolic events, including myocardial infarction, pulmonary embolism, unstable angina pectoris, etc.
- A history of hereditary bleeding prone disease or coagulation dysfunction is known.
- Poorly controlled blood pressure (defined as blood pressure ≥ 160/100mmHg under the optimal treatment of hypertension).
- Pregnant or lactating women.
- Have a history of alcohol or drug abuse.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ivonescimab Combined with Chemotherapy As First-line Treatment of Relapsed or Metastatic Thymic Cancer: a Prospective, Single Arm, Phase II Trial (iTHYM)
This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer.
Read the detailed description
This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer.
Patients who met the inclusion criteria and were pathologically confirmed to be metastatic or recurrent thymic cancer were treated with first-line treatment of Ivonescimab (20mg/kg) combined with chemotherapy (carboplatin and paclitaxel / albumin paclitaxel), and the efficacy was evaluated clinically and radiologically. The primary endpoint of this study was the 6-month progression free survival rate (PFS6m), and the secondary endpoints included PFS, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and overall survival (OS), as well as safety related research indicators including adverse events (AE) and quality of life score (QOL). During the study, biological samples were collected from patients, and exploratory studies on the efficacy and side effect biological markers of Ivonescimab were carried out.
- Being tested
- Ivonescimab Combined With Chemotherapy
- Medical subject headings
- Recurrence, Thymus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab Combined With ChemotherapyDrug
Also called AK112
Ivonescimab injection is an IgG1 subtype humanized bispecific antibody targeting human vascular endothelial growth factor-A (VEGF-A) and programmed death protein-1 (PD-1). It can bind to VEGF-A and PD-1 at the same time, and competitively block the interaction between VEGF-A, PD-1 and their ligands, exerting antitumor activity.
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab | Experimental | Ivonescimab combined with chemotherapy：Ivonescimab，20mg/kg， iv. drip, D1, Q3W；Paclitaxel, 175mg/m2 or albumin paclitaxel, 260mg/m2, iv. drip, D1, Q3W；Carboplatin, AUC5， iv.drip,D1, Q3W。After 4-6 cycles of combination therapy, Ivonescimab was maintained until PD or toxicity was intolerable. Receives: Drug: Ivonescimab Combined With Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival at 6 months（PFS 6m）
Patients who did not achieve PFS at 6 months accounted for the proportion of all patients.
Measured: Within one year after starting treatment.
Secondary outcomes (5)
Progression free survival （PFS）
The time interval from the first dose of study medication to the first record of disease progression or death from any cause, whichever occurred first.
Measured: Within two year after the first treatment
Objective response rate（ORR）
ORR, per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Measured: Within one year after starting treatment.
Disease control rate (DCR)
The proportion of subjects who achieved the best total efficacy was to confirm CR or PR or SD (according to iRECIST).
Measured: Within one year after starting treatment.
duration of remission (DOR)
The time from the first record of confirmed remission (CR or PR) to the first record of disease progression (according to irecist) or death due to any cause, whichever occurs first.
Measured: Within one year after starting treatment.
Overall survival (OS)
OS is defined as the time from the first administration of the study drug until the date of death from any cause. For subjects who are alive at the data cutoff, censoring will occur at the last known date of survival. Subjects with no follow-up information provided will be censored on the date of enrollment.
Measured: Assessed from enrollment to death or last known survival, up to 4 years post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Metastatic Thymic CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ivonescimab combined with chemotherapy
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Hou, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750952
- Sponsor's protocol ID
- B2024-646-01
- Acronym
- iTHYM
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivonescimab Combined with Chemotherapy As First-line Treatment of Relapsed or Metastatic Thymic Cancer: a Prospective, Single Arm, Phase II Trial (iTHYM)
- ClinicalTrials.gov ID
- NCT06750952
- Acronym / sponsor ID
- iTHYM / B2024-646-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 27 Dec 2024 (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 study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer.
Detailed description
This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer.
Patients who met the inclusion criteria and were pathologically confirmed to be metastatic or recurrent thymic cancer were treated with first-line treatment of Ivonescimab (20mg/kg) combined with chemotherapy (carboplatin and paclitaxel / albumin paclitaxel), and the efficacy was evaluated clinically and radiologically. The primary endpoint of this study was the 6-month progression free survival rate (PFS6m), and the secondary endpoints included PFS, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and overall survival (OS), as well as safety related research indicators including adverse events (AE) and quality of life score (QOL). During the study, biological samples were collected from patients, and exploratory studies on the efficacy and side effect biological markers of Ivonescimab were carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ivonescimab combined with chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab | Experimental | Drug: Ivonescimab Combined With ChemotherapyIvonescimab combined with chemotherapy：Ivonescimab，20mg/kg， iv. drip, D1, Q3W；Paclitaxel, 175mg/m2 or albumin paclitaxel, 260mg/m2, iv. drip, D1, Q3W；Carboplatin, AUC5， iv.drip,D1, Q3W。After 4-6 cycles of combination therapy, Ivonescimab was maintained until PD or toxicity was intolerable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Untreated metastatic or recurrent inoperable thymic cancer patients at the initial stage; All patients need to undergo baseline PET/CT (or neck, chest, upper abdominal CT+cranial MR) for clinical staging.
- The patient's age is ≥ 18 years old, with no gender restrictions.
- Pathological diagnosis of thymic carcinoma through cytology/histology.
- Expected survival period ≥ 3 months.
- ECOG (Performance Status, PS) score is 0-1 points.
Key exclusion criteria (23 listed)
- Patients with thymoma component suspected by pathological diagnosis (only thymic cancer patients were enrolled).
- The patient has or is suspected of having autoimmune disease. Note: Patients with vitiligo, type I diabetes, or Hashimoto's thyroiditis who have hypothyroidism but only need hormone replacement therapy can be included in the study when there is no obvious sign of recurrence.
- Patients need to receive systemic cortisol treatment (>10mg prednisolone [or equivalent dose] / day) or use other immunosuppressive drugs within 14 days after enrollment. Note: inhaled or topical corticosteroids, or adrenal hormone replacement therapy (>10mg prednisolone [or equivalent dose] / day) can be accepted for patients without obvious autoimmune disease.
- Patients with grade 3-4 interstitial lung disease.
- At the same time, the patient has other malignant tumors and need anti-tumor treatment.
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 |
|---|---|---|
| Ivonescimab Combined With ChemotherapyAlso: AK112Ivonescimab injection is an IgG1 subtype humanized bispecific antibody targeting human vascular endothelial growth factor-A (VEGF-A) and programmed death protein-1 (PD-1). It can bind to VEGF-A and PD-1 at the same time, and competitively block the interaction between VEGF-A, PD-1 and their ligands, exerting antitumor activity. | Drug | Ivonescimab |
Primary outcome
Progression free survival at 6 months（PFS 6m）
Time frame: Within one year after starting treatment.
Patients who did not achieve PFS at 6 months accounted for the proportion of all patients.
5 secondary outcomes
Progression free survival （PFS）
Time frame: Within two year after the first treatment
Objective response rate（ORR）
Time frame: Within one year after starting treatment.
Disease control rate (DCR)
Time frame: Within one year after starting treatment.
duration of remission (DOR)
Time frame: Within one year after starting treatment.
Overall survival (OS)
Time frame: Assessed from enrollment to death or last known survival, up to 4 years post-enrollment.
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivonescimab Combined With Chemotherapy in people with Relapsed or Metastatic Thymic Cancer and First-line Treatment, run by Sun Yat-sen University.
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 12 inclusion and 23 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: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Xue Hou, MD (+86 13570569436, houxue@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival at 6 months（PFS 6m） (time frame: Within one year after starting treatment.). 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 27 Dec 2024.