Advanced Solid TumorsPhase 1NCT06694480
Study of FID-022 in Participants With Advanced Solid Tumors
A Phase 1 study testing FID-022 in people with Advanced Solid Tumors, run by Fulgent Pharma LLC. at 3 sites in United States.
Trial summary
The goal of this Phase I Clinical Trial is to evaluate the safety and tolerability of FID-022 in patients with advanced 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?
- FID-022
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jul 2025to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to provide informed consent before the start of any study-specific procedures.
- Age ≥18 years old.
- Histologically- or cytologically confirmed malignant solid tumor that is metastatic, unresectable, progressive, or recurrent, and for which there are no standard curative measures, or for whom irinotecan is considered an appropriate palliative treatment option. Patients with known primary brain tumors will be excluded.
- Measurable disease according to RECIST version 1.1.
- Adequate treatment washout period of ≥21 days or 5 half-lives, whichever is shorter, for prior chemotherapy, radiotherapy, hormonal therapy, biological therapy, or immunotherapy before the first infusion of FID-022. Note: Palliative radiation is permitted but not ≤14 days before the first infusion of FID-022.
- ECOG PS of 0 or 1.
Show all 24Show fewer
- Recovery from any toxic effects of previous chemotherapy, immunotherapy, targeted therapy, or radiotherapy, as judged by the investigator, to Grade ≤1 according to NCI-CTCAE version 5.0 with the following exceptions: alopecia any grade; and adequately controlled anorexia, fatigue, peripheral neuropathy, or hypothyroidism that must have recovered to Grade ≤2.
- Adequate bone marrow and organ function defined as the following and these criteria need to be met:
- Bone marrow function
- ANC ≥1500/mm3 [growth factor administration is not permitted ≤2 weeks from cycle 1 day 1 (C1D1)]
- Platelet count ≥100,000/mm3 (platelet transfusion is not permitted ≤2 weeks from C1D1)
- Hemoglobin ≥10 g/dL (criteria must be met without packed red blood cell transfusion ≤2 weeks from C1D1; chronic treatment with erythropoietin is permitted if the patient is on erythropoietin for ≥8 weeks)
- Blood clotting function
- International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN) and activated partial thromboplastin time ≤1.5 × ULN (except patients who are receiving therapeutic anticoagulation and whose INR should be within the therapeutic range)
- Renal function
- Measured or Calculated creatinine clearance (using the Cockcroft Gault formula) ≥60 mL/min.
- Hepatic function
- Normal bilirubin or ≤1.0 mg/dL if the local ULN is less than 1.0 mg/dL.
- For patients with confirmed liver metastasis, total bilirubin within 1.5 x ULN limit is allowed.
- Both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN or ≤5 × ULN if liver metastases present
- An estimated life expectancy of at least 3 months based on investigator judgment.
- Male patients and female patients of childbearing potential must agree to use 2 highly effective methods of contraception or practice abstinence from 2 weeks before the first FID-022 infusion and throughout the study. After receiving the last FID-022 dose, female and male patients must agree to continue with 2 highly effective methods for at least 6 and 3 months, respectively. Male patients must refrain from donating sperm during the same period.
- Negative serum pregnancy test result at screening and on Cycle 1 Day 1 for female patients of childbearing potential.
- Female patients who are not of childbearing potential should meet at least 1 of the following criteria: have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure, or achieved postmenopausal status (defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, or have a serum follicle stimulating hormone level within the laboratory's reference range for postmenopausal women).
Who cannot join
- Known hypersensitivity to irinotecan (also called camptothecin-11 [CPT-11]) and/or similar compounds (e.g., topotecan, Trodelvy®).
- History of any secondary malignancy, with the exception of non-melanoma skin cancers and in situ cancers (such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, prostate, or breast), or has undergone potentially curative therapy with no evidence of disease recurrence for at least 2 years before the first FID-022 infusion and no additional therapy will be required during the study.
- Patients with known symptomatic active brain metastases, gliomas, leptomeningeal carcinomatosis, or spinal cord compression or other primary brain tumors. Patients with adequately treated and asymptomatic brain metastases are eligible to participate in the study. Asymptomatic brain metastases are defined as having no neurological symptoms for at least 4 weeks before the first FID-022 infusion without evidence of radiographic progression after treatment, no requirements for corticosteroids within 7 days of the first FID-022 infusion, and no lesion ≥1.5 cm at time of screening. Patients with asymptomatic brain metastases may participate but will require regular imaging of the brain as a site of disease.
- Received >3 prior lines of chemotherapy for recurrent or metastatic disease unless otherwise discussed with the sponsor's medical monitor or delegate. Chemotherapy given as part of treatment for locally advanced disease in the adjuvant or neoadjuvant setting is not considered a line of prior therapy for recurrent/metastatic disease if completed at least 6 months before the start of FID-022. Similarly, treatment with targeted agents or biologic agents such as naked antibodies as single agents or maintenance treatments will not count as a line of chemotherapy. Antibody drug conjugates are considered as lines of chemotherapy.
- Medical history of interstitial pulmonary disease, intestinal obstructions, intestinal inflammatory disease and gastrointestinal bleeding, especially those developed from prior irinotecan treatments may not be enrolled.
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders that, in the judgment of the investigator, could compromise the patient's safety or the study data integrity.
Show all 15Show fewer
- Known history of uncontrolled HIV infection defined as CD4+ cells <350/mm3.
- Patients with a positive viral load assay at time of screening for hepatitis C or hepatitis B. Patients with adequately treated viral hepatitis and a negative viral load assay are permitted.
- Requirement of systemic steroids at daily doses >10 mg prednisone equivalent systemic exposure daily, including for control of symptoms.
- Use of any UDP glucuronosyltransferase family 1 member A1 (UGT1A1) or cytochrome P450 3A4 (CYP3A4) inhibitor or UGT1A1 or CYP3A4 inducer in the previous 14 days before the first FID-022 infusion.
- Patients with known UGT1A1 deficiency including Gilbert's syndrome (GS).
- QTcF≥ 470 msec, as calculated by Fridericia formula.
- Current or recent participation in a study of an investigational product in the prior 4 weeks. Note: Patients who have completed the treatment phase of an investigational study and have entered the follow-up phase of the investigational study may participate in FID-022-001 as long as it has been ≥4 weeks before the first FID-022 infusion.
- Pregnancy, breastfeeding, or plans to become pregnant during the study or within 24 weeks after the last FID-022 infusion.
- Plans to donate/bank or retrieve eggs (ova, oocytes) during the study or within 24 weeks after the last FID-022 infusion.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Patient Portal, 877-547-9145, mycityofhope@coh.org
- Recruiting
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033
General Inquiries, 323-865-0451, uscnorrisinfo@med.usc.edu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Patient Relations, 813-699-0050, patientinput@Moffitt.org
About this study
Official title: A First-in-Human Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FID-022 as Monotherapy in Patients With Advanced Solid Tumors
The goal of this Phase I Clinical Trial is to evaluate the safety and tolerability of FID-022 in patients with advanced solid tumors.
Read the detailed description
FID-022-001 is a Phase 1, multicenter, open label dose escalation clinical study of FID-022 as monotherapy. FID-022 is composed of topoisomerase inhibitors encapsulated with a polyethyloxazoline material. The study drug is administered through intravenous route. Patients with advanced solid tumor diagnosis without standard curative treatments are the target population (please see the eligibility section)
- Conditions
- Advanced Solid Tumors
- Being tested
- FID-022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID-022Drug
FID-022 is composed of SN38 and irinotecan (a prodrug of SN38) that are encapsulated with a polyethyloxazoline (PEOX) material.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation - Weekly Dose | Experimental | Patients will be sequentially enrolled at progressively higher dose levels to receive FID-022 as monotherapy. According to the study design, maintaining the dose level or moving down a dose level will possibly happen when conditions are met.
Intravenous Administration of FID-022, infusion on day 1 and 8 of each 21-day cycle:
Dose level 1: 20 mg/m2. Dose level 2: 40 mg/m2. Dose level 3: 60 mg/m2. Dose level 4: 80 mg/m2. Dose level 5: 100 mg/m2. Dose level 6: 120 mg/m2. Receives: Drug: FID-022 |
| Dose Escalation - Bi-weekly Dose | Experimental | Patients will be sequentially enrolled at progressively higher dose levels to receive FID-022 as monotherapy. According to the study design, maintaining the dose level or moving down a dose level will possibly happen when conditions are met.
Intravenous Administration of FID-022, infusion on day 1 and 15 of each 28-day cycle:
Dose level 1: 20 mg/m2. Dose level 2: 40 mg/m2. Dose level 3: 60 mg/m2. Dose level 4: 80 mg/m2. Dose level 5: 100 mg/m2. Dose level 6: 120 mg/m2. Receives: Drug: FID-022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD determination
Determine the Maximum Tolerated Dose (MTD) of FID-022 in patients with advanced solid tumors
Measured: Through study completion, approximately 2.5 years
Number of participants with a treatment-related adverse events as assessed by NCI-CTCAE version 5.0.
Frequency and severity of abnormal clinical laboratory results, adverse events (AEs), severity of serious AEs (SAEs) and deaths graded according to the NCI-CTCAE version 5.0
Measured: Through study completion, approximately 2.5 years
Number of Participants with Dose Limiting Toxicity (DLT) events during the DLT monitoring period (first 21 days of dosing)
DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 .0. Maximum tolerated dose (MTD) will be determined based on DLT per protocol.
Measured: 21 days
Secondary outcomes (9)
Pharmacokinetic (PK) parameters: Maximum observed plasma concentration (Cmax) of FID-022 and its components, major metabolites
Identify the peak plasma concentration Cmax for 1). FID-022 as the original drug, 2). released two active components and 3). major known metabolites.
Measured: Up to Day 22
Pharmacokinetic (PK) parameters: Time to the maximum observed plasma concentration (Tmax) of FID-022 and its components, major metabolites
Determine time to the maximum observed plasma concentration (Tmax) for 1). FID-022 as the original drug, 2). released two active components and 3). major known metabolites.
Measured: Up to Day 22
Pharmacokinetic (PK) parameters: Area under the plasma concentration time curve (AUC0-t) of FID-022 and its components, major metabolites
Calculated area under the plasma concentration time curve (AUC0-t) of FID-022 with a focus on the key active component.
Measured: Up to Day 22
Pharmacokinetic (PK) parameters: Area under the plasma concentration time curve (AUC0-∞) of FID-022 and its components, major metabolites
Calculated area under the plasma concentration time curve (AUC0-∞) of FID-022 with a focus on the key active component.
Measured: Up to Day 22
Tumor Response Assessment: Objective Response Rate (ORR) determined by the Investigator
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Through study completion, approximately 2.5 years
Tumor Response Assessment: Disease control rate (DCR) determined by the Investigator
DCR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) or a stable disease (SD) for at least 4 weeks or longer based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Through study completion, approximately 2.5 years
Tumor Response Assessment: Duration of response (DOR)
Duration of overall response is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first.
Measured: Through study completion, approximately 2.5 years
Tumor Response Assessment: Time to Response (TTR)
TTR is defined as the time from the initial dosing to the date of first documented response to the treatment, e.g. complete response or partial response, assessed by investigator and based on RECIST v. 1.1.
Measured: Through study completion, approximately 2.5 years
Tumor Response Assessment: Progression free survival (PFS)
PFS defined as the time from the date the participant started study drug to the date the participant experiences an event of radiographic disease progression, clinical progression or death.
Measured: Through study completion, approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start3 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
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.
- 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
- Model description
- FID-022 treatment Single arm study with 6 planned dose levels. Intravenous Administration of FID-022, infusion on day 1 and 8 of each 21-day cycle, or on day 1 and 15 of each 28-day cycle: Dose level 1: 20 mg/m2. Dose level 2: 40 mg/m2. Dose level 3: 60 mg/m2. Dose level 4: 80 mg/m2. Dose level 5: 100 mg/m2. Dose level 6: 120 mg/m2.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fulgent Pharma LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694480
- Sponsor's protocol ID
- FID-022-001
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FID-022 as Monotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06694480
- Acronym / sponsor ID
- FID-022-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fulgent Pharma LLC.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 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.
The goal of this Phase I Clinical Trial is to evaluate the safety and tolerability of FID-022 in patients with advanced solid tumors.
Detailed description
FID-022-001 is a Phase 1, multicenter, open label dose escalation clinical study of FID-022 as monotherapy. FID-022 is composed of topoisomerase inhibitors encapsulated with a polyethyloxazoline material. The study drug is administered through intravenous route. Patients with advanced solid tumor diagnosis without standard curative treatments are the target population (please see the eligibility section)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- FID-022 treatment Single arm study with 6 planned dose levels. Intravenous Administration of FID-022, infusion on day 1 and 8 of each 21-day cycle, or on day 1 and 15 of each 28-day cycle: Dose level 1: 20 mg/m2. Dose level 2: 40 mg/m2. Dose level 3: 60 mg/m2. Dose level 4: 80 mg/m2. Dose level 5: 100 mg/m2. Dose level 6: 120 mg/m2.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation - Weekly Dose | Experimental | Drug: FID-022Patients will be sequentially enrolled at progressively higher dose levels to receive FID-022 as monotherapy. According to the study design, maintaining the dose level or moving down a dose level will possibly happen when conditions are met. Intravenous Administration of FID-022, infusion on day 1 and 8 of each 21-day cycle: Dose level 1: 20 mg/m2. Dose level 2: 40 mg/m2. Dose level 3: 60 mg/m2. Dose level 4: 80 mg/m2. Dose level 5: 100 mg/m2. Dose level 6: 120 mg/m2. |
| Dose Escalation - Bi-weekly Dose | Experimental | Drug: FID-022Patients will be sequentially enrolled at progressively higher dose levels to receive FID-022 as monotherapy. According to the study design, maintaining the dose level or moving down a dose level will possibly happen when conditions are met. Intravenous Administration of FID-022, infusion on day 1 and 15 of each 28-day cycle: Dose level 1: 20 mg/m2. Dose level 2: 40 mg/m2. Dose level 3: 60 mg/m2. Dose level 4: 80 mg/m2. Dose level 5: 100 mg/m2. Dose level 6: 120 mg/m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Ability to understand and willingness to provide informed consent before the start of any study-specific procedures.
- Age ≥18 years old.
- Histologically- or cytologically confirmed malignant solid tumor that is metastatic, unresectable, progressive, or recurrent, and for which there are no standard curative measures, or for whom irinotecan is considered an appropriate palliative treatment option. Patients with known primary brain tumors will be excluded.
- Measurable disease according to RECIST version 1.1.
- Adequate treatment washout period of ≥21 days or 5 half-lives, whichever is shorter, for prior chemotherapy, radiotherapy, hormonal therapy, biological therapy, or immunotherapy before the first infusion of FID-022. Note: Palliative radiation is permitted but not ≤14 days before the first infusion of FID-022.
Key exclusion criteria (15 listed)
- Known hypersensitivity to irinotecan (also called camptothecin-11 [CPT-11]) and/or similar compounds (e.g., topotecan, Trodelvy®).
- History of any secondary malignancy, with the exception of non-melanoma skin cancers and in situ cancers (such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, prostate, or breast), or has undergone potentially curative therapy with no evidence of disease recurrence for at least 2 years before the first FID-022 infusion and no additional therapy will be required during the study.
- Patients with known symptomatic active brain metastases, gliomas, leptomeningeal carcinomatosis, or spinal cord compression or other primary brain tumors. Patients with adequately treated and asymptomatic brain metastases are eligible to participate in the study. Asymptomatic brain metastases are defined as having no neurological symptoms for at least 4 weeks before the first FID-022 infusion without evidence of radiographic progression after treatment, no requirements for corticosteroids within 7 days of the first FID-022 infusion, and no lesion ≥1.5 cm at time of screening. Patients with asymptomatic brain metastases may participate but will require regular imaging of the brain as a site of disease.
- Received >3 prior lines of chemotherapy for recurrent or metastatic disease unless otherwise discussed with the sponsor's medical monitor or delegate. Chemotherapy given as part of treatment for locally advanced disease in the adjuvant or neoadjuvant setting is not considered a line of prior therapy for recurrent/metastatic disease if completed at least 6 months before the start of FID-022. Similarly, treatment with targeted agents or biologic agents such as naked antibodies as single agents or maintenance treatments will not count as a line of chemotherapy. Antibody drug conjugates are considered as lines of chemotherapy.
- Medical history of interstitial pulmonary disease, intestinal obstructions, intestinal inflammatory disease and gastrointestinal bleeding, especially those developed from prior irinotecan treatments may not be enrolled.
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 |
|---|---|---|
| FID-022FID-022 is composed of SN38 and irinotecan (a prodrug of SN38) that are encapsulated with a polyethyloxazoline (PEOX) material. | Drug | Dose Escalation - Bi-weekly Dose, Dose Escalation - Weekly Dose |
Primary outcome
MTD determination
Time frame: Through study completion, approximately 2.5 years
Determine the Maximum Tolerated Dose (MTD) of FID-022 in patients with advanced solid tumors
Number of participants with a treatment-related adverse events as assessed by NCI-CTCAE version 5.0.
Time frame: Through study completion, approximately 2.5 years
Frequency and severity of abnormal clinical laboratory results, adverse events (AEs), severity of serious AEs (SAEs) and deaths graded according to the NCI-CTCAE version 5.0
Number of Participants with Dose Limiting Toxicity (DLT) events during the DLT monitoring period (first 21 days of dosing)
Time frame: 21 days
DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 .0. Maximum tolerated dose (MTD) will be determined based on DLT per protocol.
9 secondary outcomes
Pharmacokinetic (PK) parameters: Maximum observed plasma concentration (Cmax) of FID-022 and its components, major metabolites
Time frame: Up to Day 22
Pharmacokinetic (PK) parameters: Time to the maximum observed plasma concentration (Tmax) of FID-022 and its components, major metabolites
Time frame: Up to Day 22
Pharmacokinetic (PK) parameters: Area under the plasma concentration time curve (AUC0-t) of FID-022 and its components, major metabolites
Time frame: Up to Day 22
Pharmacokinetic (PK) parameters: Area under the plasma concentration time curve (AUC0-∞) of FID-022 and its components, major metabolites
Time frame: Up to Day 22
Tumor Response Assessment: Objective Response Rate (ORR) determined by the Investigator
Time frame: Through study completion, approximately 2.5 years
Tumor Response Assessment: Disease control rate (DCR) determined by the Investigator
Time frame: Through study completion, approximately 2.5 years
Tumor Response Assessment: Duration of response (DOR)
Time frame: Through study completion, approximately 2.5 years
Tumor Response Assessment: Time to Response (TTR)
Time frame: Through study completion, approximately 2.5 years
Tumor Response Assessment: Progression free survival (PFS)
Time frame: Through study completion, approximately 2.5 years
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 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
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
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FID-022 in people with Advanced Solid Tumors, run by Fulgent Pharma LLC. at 3 sites in United States.
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 24 inclusion and 15 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 Fulgent Pharma (626-434-8896, info@fulgentpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD determination (time frame: Through study completion, approximately 2.5 years). 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 8 Sep 2026.