Advanced Solid TumorsPhase 1NCT05718219
Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors
A Phase 1 study testing SIM0348 and SIM0348 + Sintilimab in people with Advanced Solid Tumors, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy or with sintilimab in adult subjects with advanced and metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SIM0348 and SIM0348 + Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2023to 30 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older
- Must have failed at least one established standard anti-cancer therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy at least 12 weeks
- Adequate hematologic and end organ function
- Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care
- Confirmed availability of representative tumor specimens
- Measurable disease according to RECIST Version 1.1
Who cannot join
- Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1
- Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
- History of interstitial lung disease, evidence of active pneumonitis (history of radiation pneumonitis in the radiation field [fibrosis] is permitted), and active pneumonia that are considered inappropriate by the investigator
- History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- History of autoimmune disease
- Positive human immunodeficiency virus (HIV) test
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- Severe infection within 2 weeks prior to the first dose of study treatment
- Significant cardiovascular disease
- History of allogeneic tissue/solid organ transplant or graft-versus-host disease
- Known clinically significant liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, First-in-Human, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Subjects With Advanced Solid Tumors
This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy or with sintilimab in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).
- Conditions
- Advanced Solid Tumors
- Being tested
- SIM0348, SIM0348 + Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0348Drug
Several dose levels will be evaluated for SIM0348 administered as a single agent . SIM0348 will be given via IV infusion on Day 1, Day 8, Day 15, Day 22 of each cycle (28-day or depending on study cohort and phase) until disease progression or loss of clinical benefit.
SIM0348 + SintilimabDrug
Selected doses from Part 1A will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Part 1A ( SIM0348 Monotherapy) | Experimental | Part 1A (dose escalation and dose expansion) Cohorts of at least 3 participants each will be treated with escalating doses of SIM0348 alone or in combination with Sintilimab . Dose expansion part will be decided based on the findings of dose escalation part. Part 1A was to evaluate single agent SIM0348 once weekly or once every 3 weeks. Receives: Drug: SIM0348 |
| Part 1B (SIM0348 + Sintilimab ) | Experimental | Part 1B (dose escalation and dose expansion) Cohorts of at least 3 participants each will be treated with escalating doses of SIM0348 alone or in combination with Sintilimab. Dose expansion part will be decided based on the findings of dose escalation part. In Part 1B, selected dose from Part 1A were evaluated in Part 1B when they were combined with Sintilimab (200mg once every 3 weeks) Receives: Drug: SIM0348 + Sintilimab |
| Part 2A (SIM0348 Monotherapy Cohort Expansion) | Experimental | Selected doses from Part 1A will be evaluated for SIM0348 administered as a single agent. SIM0348 will be given via IV infusion until disease progression or loss of clinical benefit. Receives: Drug: SIM0348 |
| Part 2B (SIM0348 + Sintilimab Cohort Expansion) | Experimental | Selected doses from Part 1B will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks) Receives: Drug: SIM0348 + Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Dose-limiting toxicity (DLT)
Measured: DLT evaluation window was from Baseline to the end of Cycle 1 (up to 28 days)
Part 2: Objective response rate (ORR) assessed by Investigator per RECIST v.1.1
To evaluate the anti-tumor activity of SIM0348 alone and in combination with Sintilimab
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start29 Mar 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2026
Why it stopped: Business decision
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.
- More trials run by Jiangsu Simcere 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718219
- Sponsor's protocol ID
- SIM0348-101
- Status last verified
- Apr 2025
- First submitted
- 29 Jan 2023
- Last updated
- 25 Aug 2026
- Results posted
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-Human, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05718219
- Acronym / sponsor ID
- SIM0348-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 8 Feb 2023 (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 multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy or with sintilimab in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1A ( SIM0348 Monotherapy) | Experimental | Drug: SIM0348Part 1A (dose escalation and dose expansion) Cohorts of at least 3 participants each will be treated with escalating doses of SIM0348 alone or in combination with Sintilimab . Dose expansion part will be decided based on the findings of dose escalation part. Part 1A was to evaluate single agent SIM0348 once weekly or once every 3 weeks. |
| Part 1B (SIM0348 + Sintilimab ) | Experimental | Drug: SIM0348 + SintilimabPart 1B (dose escalation and dose expansion) Cohorts of at least 3 participants each will be treated with escalating doses of SIM0348 alone or in combination with Sintilimab. Dose expansion part will be decided based on the findings of dose escalation part. In Part 1B, selected dose from Part 1A were evaluated in Part 1B when they were combined with Sintilimab (200mg once every 3 weeks) |
| Part 2A (SIM0348 Monotherapy Cohort Expansion) | Experimental | Drug: SIM0348Selected doses from Part 1A will be evaluated for SIM0348 administered as a single agent. SIM0348 will be given via IV infusion until disease progression or loss of clinical benefit. |
| Part 2B (SIM0348 + Sintilimab Cohort Expansion) | Experimental | Drug: SIM0348 + SintilimabSelected doses from Part 1B will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults 18 years of age or older
- Must have failed at least one established standard anti-cancer therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy at least 12 weeks
- Adequate hematologic and end organ function
Key exclusion criteria (10 listed)
- Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1
- Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
- History of interstitial lung disease, evidence of active pneumonitis (history of radiation pneumonitis in the radiation field [fibrosis] is permitted), and active pneumonia that are considered inappropriate by the investigator
- History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- History of autoimmune disease
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 |
|---|---|---|
| SIM0348Several dose levels will be evaluated for SIM0348 administered as a single agent . SIM0348 will be given via IV infusion on Day 1, Day 8, Day 15, Day 22 of each cycle (28-day or depending on study cohort and phase) until disease progression or loss of clinical benefit. | Drug | Part 1A ( SIM0348 Monotherapy), Part 2A (SIM0348 Monotherapy Cohort Expansion) |
| SIM0348 + SintilimabSelected doses from Part 1A will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks). | Drug | Part 1B (SIM0348 + Sintilimab ), Part 2B (SIM0348 + Sintilimab Cohort Expansion) |
Primary outcome
Part 1: Dose-limiting toxicity (DLT)
Time frame: DLT evaluation window was from Baseline to the end of Cycle 1 (up to 28 days)
Part 2: Objective response rate (ORR) assessed by Investigator per RECIST v.1.1
Time frame: up to approximately 2 years
To evaluate the anti-tumor activity of SIM0348 alone and in combination with Sintilimab
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SIM0348 and SIM0348 + Sintilimab in people with Advanced Solid Tumors, run by Jiangsu Simcere 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 25 Aug 2026. 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?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Dose-limiting toxicity (DLT) (time frame: DLT evaluation window was from Baseline to the end of Cycle 1 (up to 28 days)). The study lists 2 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 25 Aug 2026.