Malignant TumorsPhase 1NCT06944444
A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors
A Phase 1 study testing SSS59 in people with Malignant Tumors, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Tumors
- What is being tested?
- SSS59
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2025to 31 Dec 2027
- Phase
- Phase 1
- 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
- Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >3 months.
- Signed informed consent form.
- Must have adequate organ function.
Who cannot join
- Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss and fatigue.
- Pregnant or nursing women or women/men who are ready to give birth.
- symptomatic central nervous system metastasis.
- Allergy to other antibody drugs or any excipients in the study drugs.
- Underwent major surgery within 4 weeks prior to first dosing.
- The patient is participating in another clinical study, unless it is an observational (non-intervention) clinical study or a follow-up period of an intervention study.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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 First People's Hospital
Shanghai, Shanghai Municipality
Wenqian Geng, 86+021-36126254, shiyilunli@sina.com
About this study
Official title: A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors
This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.
Read the detailed description
This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).
- Conditions
- Malignant Tumors
- Being tested
- SSS59
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS59Drug
A humanized antibody targeting MUC17
| Study group | Role | What they receive |
|---|---|---|
| Part A1 | Experimental | Dose escalation will be conducted using accelerated titration and traditional 3+3 design. Dose Escalation Level includes 12 levels, QW IV. Dose extension will be carried out at the selected level. Receives: Drug: SSS59 |
| Part A2 | Experimental | Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level includes 12 levels, Q2W IV. Dose extension will be carried out at the selected level. Receives: Drug: SSS59 |
| Part A3 | Experimental | Dose extension will be carried out at the selected dose level, Q3W, IV. Receives: Drug: SSS59 |
| Part B | Experimental | Indication extension will be carried out at the selected level. Receives: Drug: SSS59 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
Dose limiting toxicity
Measured: 21 days
Safety and tolerability
Safety and tolerability assessed by incidence and severity of adverse events
Measured: during the intervention，Within 28 days of the last dose
MTD and RP2D
Determine the maximum tolerated dose and determine the recommended phase II dose
Measured: through study completion, an average of 2 year
Secondary outcomes (7)
Cmax of SSS59
Maximum concentration
Measured: baseline, during the intervention and at the end of the study
Tmax of SSS59
Time to peak drug concentration
Measured: baseline, during the intervention and at the end of the study
AUC0-last of SSS59
the area under the curve (AUC) up to the last measurable concentration
Measured: baseline, during the intervention and at the end of the study
RO of SSS59
Receptor Occupancy
Measured: baseline, during the intervention and at the end of the study
Pharmacodynamic (PD) characteristics of SSS59
change of cytokine
Measured: baseline, during the intervention and at the end of the study
Immunogenicity of SSS59
ADA，NAB（if ADA is positive）
Measured: baseline, during the intervention and at the end of the study
Preliminary antitumor activity of SSS59
Assessed according to Recist V1.1
Measured: baseline, during the intervention and at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start27 Apr 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine 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
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944444
- Sponsor's protocol ID
- SSS59-101
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 29 Apr 2025
- 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 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT06944444
- Acronym / sponsor ID
- SSS59-101
- Conditions
- Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Apr 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 study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.
Detailed description
This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A1 | Experimental | Drug: SSS59Dose escalation will be conducted using accelerated titration and traditional 3+3 design. Dose Escalation Level includes 12 levels, QW IV. Dose extension will be carried out at the selected level. |
| Part A2 | Experimental | Drug: SSS59Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level includes 12 levels, Q2W IV. Dose extension will be carried out at the selected level. |
| Part A3 | Experimental | Drug: SSS59Dose extension will be carried out at the selected dose level, Q3W, IV. |
| Part B | Experimental | Drug: SSS59Indication extension will be carried out at the selected level. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >3 months.
- Signed informed consent form.
- Must have adequate organ function.
Key exclusion criteria (7 listed)
- Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss and fatigue.
- Pregnant or nursing women or women/men who are ready to give birth.
- symptomatic central nervous system metastasis.
- Allergy to other antibody drugs or any excipients in the study drugs.
- Underwent major surgery within 4 weeks prior to first dosing.
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 |
|---|---|---|
| SSS59A humanized antibody targeting MUC17 | Drug | Part A1, Part A2, Part A3, Part B |
Primary outcome
DLTs
Time frame: 21 days
Dose limiting toxicity
Safety and tolerability
Time frame: during the intervention，Within 28 days of the last dose
Safety and tolerability assessed by incidence and severity of adverse events
MTD and RP2D
Time frame: through study completion, an average of 2 year
Determine the maximum tolerated dose and determine the recommended phase II dose
7 secondary outcomes
Cmax of SSS59
Time frame: baseline, during the intervention and at the end of the study
Tmax of SSS59
Time frame: baseline, during the intervention and at the end of the study
AUC0-last of SSS59
Time frame: baseline, during the intervention and at the end of the study
RO of SSS59
Time frame: baseline, during the intervention and at the end of the study
Pharmacodynamic (PD) characteristics of SSS59
Time frame: baseline, during the intervention and at the end of the study
Immunogenicity of SSS59
Time frame: baseline, during the intervention and at the end of the study
Preliminary antitumor activity of SSS59
Time frame: baseline, during the intervention and at the end of the study
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 29 Apr 2025.
- 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.
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 SSS59 in people with Malignant Tumors, run by Shenyang Sunshine 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 5 inclusion and 7 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 29 Apr 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 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?
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 Qi Li, MD (86+13818207333, Leeqi2001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs (time frame: 21 days). The study lists 3 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 29 Apr 2025.