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DF6002 for Melanoma

Phase-Based Progress Estimates

Effectiveness

Safety

Melanoma+11 MoreDF6002 - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial will test the safety and effectiveness of a new drug, DF6002, either alone or in combination with another drug, nivolumab, in people with advanced solid tumors.

Eligible Conditions

Melanoma
Head and Neck Squamous Cell Carcinoma (HNSCC)
Esophageal Cancer
Breast Cancer
Kidney Cancer
Bladder Cancer
Lung Cancer
Endometrial Cancer
Stomach Cancer
Ovarian Cancer
Prostate Cancer
Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

HFB200301

Phase Ib: Dose Escalation

Study Objectives

5 Primary · 28 Secondary · Reporting Duration: Approximately one year

Approximately one year

Best overall response (BOR) according to RECIST 1.1 per Investigator assessment

Week 3

Number of participants with dose-limiting toxicities (DLTs)

Week 3

Assessment of the number of dose limiting toxicities experienced on study with combination therapy of DF6002 and nivolumab as defined per criteria in the study protocol

Week 3

Assessment of the number of dose limiting toxicities experienced on study with monotherapy DF6002 as defined per criteria in the study protocol

Day 28

Determine serum concentrations of DF6002 at various timepoints

Month 24

Assess Duration of Response

Year 1

Assess Best Overall Response

Year 1

Assess overall response rate

Year 2

Assess Overall Survival

Year 2

Assess Overall Response Rate

Day 30

Assess number of treatment emergent adverse events throughout study

Up to 2 years

CBR according to RECIST 1.1 per IERC

Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment

Confirmed ORR per RECIST 1.1 per Investigator assessment

Duration of TEAEs

Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status

Number of participants with changes from baseline in clinical laboratory parameters

Number of participants with changes from baseline in electrocardiogram (ECG) parameters

Number of participants with changes from baseline in vital sign parameters

Number of participants with treatment emergent adverse events (TEAEs)

Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)

PFS according to RECIST 1.1 per IERC

Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment

Serum titers of anti-DF6002 antibodies

Serum titers of anti-nivolumab antibodies

Severity of TEAEs

Unconfirmed response after 4 cycles according to RECIST 1.1

Up to 5 years

Overall Survival (OS)

Up to day 28

Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)

Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T)

Maximum serum concentration observed post-dose (Cmax)

Up to month 24

DOR according to RECIST 1.1 per IERC

Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment

Trial Safety

Safety Progress

1 of 3

HFB200301

Phase Ib: Dose Escalation

Side Effects for

NIVOLUMAB 3 mg/kg

38%Fatigue

29%Nausea

28%Decreased appetite

25%Cough

25%Diarrhoea

24%Dyspnoea

20%Vomiting

19%Constipation

14%Anaemia

14%Weight decreased

13%Malignant neoplasm progression

13%Aspartate aminotransferase increased

13%Arthralgia

13%Back pain

13%Pruritus

12%Pyrexia

12%Rash

11%Oedema peripheral

10%Dizziness

10%Myalgia

10%Productive cough

10%Abdominal pain

9%Non-cardiac chest pain

9%Alanine aminotransferase increased

9%Hypoalbuminaemia

9%Hyponatraemia

9%Headache

8%Asthenia

7%Hypothyroidism

7%Upper respiratory tract infection

7%Hypokalaemia

7%Musculoskeletal pain

6%Insomnia

6%Chills

6%Nasopharyngitis

6%Lymphocyte count decreased

6%Blood alkaline phosphatase increased

6%Hyperglycaemia

6%Musculoskeletal chest pain

6%Pain in extremity

6%Haemoptysis

6%Dry skin

6%Dyspepsia

5%Dysgeusia

5%Hypomagnesaemia

5%Rash maculo-papular

4%Pneumonia

4%Blood creatinine increased

4%Muscular weakness

3%Stomatitis

3%Chest pain

3%Hypophosphataemia

3%Dysphonia

3%Pneumonitis

2%Pleural effusion

2%Pulmonary embolism

2%Mucosal inflammation

2%Peripheral sensory neuropathy

2%Alopecia

2%Lung infection

2%Pericardial effusion malignant

2%Epistaxis

1%Acute coronary syndrome

1%Adrenal insufficiency

1%General physical health deterioration

1%Hypersensitivity

1%Urinary tract infection

1%Hip fracture

1%Infusion related reaction

1%Gamma-glutamyltransferase increased

1%Dehydration

1%Hypercalcaemia

1%Pathological fracture

1%Malignant pleural effusion

1%Cancer pain

1%Lung neoplasm malignant

1%Cerebrovascular accident

1%Confusional state

1%Metastases to spine

1%Syncope

1%Chronic obstructive pulmonary disease

1%Renal failure

1%Pneumothorax

1%Respiratory failure

1%Pulmonary haemorrhage

1%Deep vein thrombosis

1%Lacrimation increased

1%Neutropenia

1%Thrombocytopenia

1%Platelet count decreased

1%Neutrophil count decreased

1%Colitis

1%Cholecystitis acute

1%Sepsis

1%Lower respiratory tract infection

1%Metastases to central nervous system

1%Tumour pain

1%Seizure

1%White blood cell count decreased

This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

Trial Design

12 Treatment Groups

DF6002 Monotherapy Expansion (NSCLC)

1 of 12

DF6002 in Combination with Opdivo Expansion (Melanoma)

1 of 12

DF6002 Monotherapy Dose Escalation

1 of 12

DF6002 in Combination with Opdivo Expansion (NSCLC)

1 of 12

DF6002 Monotherapy Expansion (Melanoma)

1 of 12

DF6002 In Combination with Opdivo Escalation

1 of 12

Combination Dose Expansion (Melanoma)

1 of 12

Combination Dose Expansion (NSCLC)

1 of 12

Monotherapy Dose Expansion (Melanoma)

1 of 12

Monotherapy Dose Expansion (NSCLC)

1 of 12

Monotherapy Dose Escalation

1 of 12

Combination Dose Escalation

1 of 12

Experimental Treatment

473 Total Participants · 12 Treatment Groups

Primary Treatment: DF6002 · No Placebo Group · Phase 1 & 2

DF6002 Monotherapy Expansion (NSCLC)

Drug