Advanced CancerPhase 1NCT06707610
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
A Phase 1 study testing ALK202 in people with Advanced Cancer and Advanced Solid Tumor, run by Shanghai Allink Biotherapeutics Co., Ltd. at 4 sites in 2 countries.
Trial summary
TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancer, Advanced Solid Tumor
- What is being tested?
- ALK202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Feb 2025to Dec 2028
- 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
- Men and women ≥18 and ≤75 years old on the day of signing the ICF
- At least 1 measurable lesion per RECIST v1.1
- Expected survival ≥3 months
- ECOG PS score of 0 or 1
- Adequate organ function
- Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the ICF until at least 6 months after the last dose of ALK202, and during this period, male participants are not allowed to donate sperms.
Who cannot join
- Received organ transplant or hematopoietic stem cell transplant previously
- Vaccinated with live vaccines within 4 weeks prior to the first dose
- Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
- Pregnant or lactating women
- Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.
- Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Next Oncology
Fairfax, Virginia, 22031
Dr. Alex Apira, +1 7032805390, aspira@nextoncology.com
- Recruiting
D&H Cancer Research Center Llc
Margate, Florida, 33063
Dr. David Kahn, +1 9543232422, Drdkahn@dhnrc.com
Australia2 sites, 2 recruiting
- Recruiting
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
Dr. Charlotte Lemech, +61 2 93825807, Charlotte.lemech@scientiaclinicalresearch.com.au
- Recruiting
Macquarie University
Sydney, New South Wales, 2109
Dr. John Park, +61 2 98123000, John.park@mqhealth.org.au
About this study
Official title: A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors
TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.
- Conditions
- Advanced Cancer, Advanced Solid Tumor
- Being tested
- ALK202
- Keywords
- First-in-human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK202Drug
Administered intravenously, once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose-escalation Phase Part B: Dose-expansion Phase | Experimental | A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B). A dose-expansion study which will enroll the select indications. Receives: Drug: ALK202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies.
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
Measured: Approximately 36 months
Secondary outcomes (16)
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: trough Concentration(Ctrough)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: Clearance(CL)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: apparent Distribution Volume(Vd)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)
Measured: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: terminal half-life (t1/2)
Measured: Approximately 36 months
To evaluate the immunogenicity of ALK202
The generation of anti-drug antibodies (ADAs)
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Objective Response Rate (ORR)
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Duration of Response (DOR)
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Disease Control Rate (DCR)
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Progression-Free Survival (PFS)
Measured: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Overall Survival (OS)
Measured: Approximately 36 months
To evaluate the biomarkers
To explore the correlation between biomarkers (EGFR/c-MET) and the efficacy and other clinical outcomes/parameters of ALK202
Measured: Approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start10 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707610
- Sponsor's protocol ID
- ALK202-01
- Status last verified
- Mar 2025
- First submitted
- 25 Nov 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06707610
- Acronym / sponsor ID
- ALK202-01
- Conditions
- Advanced Cancer, Advanced Solid Tumor
- Keywords
- First-in-human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Nov 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.
TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose-escalation Phase Part B: Dose-expansion Phase | Experimental | Drug: ALK202A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B). A dose-expansion study which will enroll the select indications. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ≥18 and ≤75 years old on the day of signing the ICF
- At least 1 measurable lesion per RECIST v1.1
- Expected survival ≥3 months
- ECOG PS score of 0 or 1
- Adequate organ function
Key exclusion criteria (7 listed)
- Received organ transplant or hematopoietic stem cell transplant previously
- Vaccinated with live vaccines within 4 weeks prior to the first dose
- Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
- Pregnant or lactating women
- Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.
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 |
|---|---|---|
| ALK202Administered intravenously, once every 3 weeks | Drug | Part A: Dose-escalation Phase Part B: Dose-expansion Phase |
Primary outcome
To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies.
Time frame: Approximately 36 months
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
16 secondary outcomes
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the immunogenicity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the biomarkers
Time frame: Approximately 36 months
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 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALK202 in people with Advanced Cancer and Advanced Solid Tumor, run by Shanghai Allink Biotherapeutics Co., Ltd. at 4 sites in 2 countries.
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 6 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. 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 Shuntong Duan (8618005141727, stduan@allinkbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies. (time frame: Approximately 36 months). 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 12 Mar 2025.